HEALIX ADVANCERecalls & reported problems across all models
Medos International Sàrl · 21 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 463
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls
- 0
We found 21 models of HEALIX ADVANCE by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 463 adverse event reports in the FDA's MAUDE database, received between Aug 7, 2018 and Sep 29, 2026 — classified as 50 injuries, 413 malfunctions.
The most frequently reported specific device problem is “Break” (185 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported HEALIX ADVANCE problems
Device problems
- Break185
- Difficult to Advance52
- Material Deformation44
- Crack43
- Migration33
- Adverse Event Without Identified Device or Use Problem32
- Device-Device Incompatibility27
- Detachment of Device or Device Component25
Patient problems
- No Clinical Signs, Symptoms or Conditions327
- No Consequences Or Impact To Patient60
- Unspecified Tissue Injury32
- Not Applicable25
- Unspecified Infection9
- Foreign Body In Patient8
- Injury5
- Loss of Range of Motion4
HEALIX ADVANCE models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HEALIX ADVANCE 222422Fastener, fixation, biodegradable, soft tissue113 reports
- HEALIX ADVANCE 222424Fastener, fixation, biodegradable, soft tissue105 reports
- HEALIX ADVANCE 222425Fastener, fixation, nondegradable, soft tissue47 reports
- HEALIX ADVANCE 222314ORTHOPEDIC MANUAL SURGICAL INSTRUMENT32 reports
- HEALIX ADVANCE 222581Fastener, fixation, biodegradable, soft tissue32 reports
- HEALIX ADVANCE 222423Fastener, fixation, nondegradable, soft tissue31 reports
- HEALIX ADVANCE 222315ORTHOPEDIC MANUAL SURGICAL INSTRUMENT21 reports
- HEALIX ADVANCE 222582Fastener, fixation, biodegradable, soft tissue20 reports
- HEALIX ADVANCE 222584Fastener, fixation, nondegradable, soft tissue12 reports
- HEALIX ADVANCE 222585Fastener, fixation, nondegradable, soft tissue12 reports
- HEALIX ADVANCE 222316ORTHOPEDIC MANUAL SURGICAL INSTRUMENT9 reports
- HEALIX ADVANCE 222326ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6 reports
- HEALIX ADVANCE 222426Fastener, fixation, biodegradable, soft tissue6 reports
- HEALIX ADVANCE 222583Fastener, fixation, biodegradable, soft tissue5 reports
- HEALIX ADVANCE 222327ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- HEALIX ADVANCE 222317ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- HEALIX ADVANCE 222427Fastener, fixation, nondegradable, soft tissue2 reports
- HEALIX ADVANCE 222328ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- HEALIX ADVANCE 222329ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- HEALIX ADVANCE 222358ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- HEALIX ADVANCE 222586Fastener, fixation, nondegradable, soft tissue1 report
Recent HEALIX ADVANCE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
It was reported that during an arthroscopic rotator cuff repair procedure the 5.5MM HEALX ADV SP BIOC ANCHOR device broke and could no longer be used. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no adverse patient consequences reported. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930918 ↗MalfunctionSep 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740812 ↗MalfunctionSep 10, 2026Break; Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715737 ↗MalfunctionSep 1, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50549721 ↗MalfunctionSep 1, 2026Detachment of Device or Device Component
It was reported that during an Arthroscopic Rotator Cuff Repair (ARCR) for a shoulder surgery following ASD, two Helix anchors devices pre-loaded with Permatape were inserted medially and sutures were passed through the rotator cuff. When the surgeon tried to pass the medial anchor sutures through the HASP 5.5 bridge anchor pulling the suture kite caused it to detach from the anchor. As the suture kite could not be reattached, a new anchor was used to continue the surgery; it functioned without issue. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50545001 ↗MalfunctionAug 26, 2026Break
It was reported that during an Arthroscopic Rotator Cuff Repair (ARCR) surgery, while using the 5.5MM HEALX ADV SP BIOC ANCHOR device when the suture was being threaded through the anchor with a needle threader, the wire of needle threader snapped. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50452348 ↗MalfunctionJun 16, 2026Break
IT WAS REPORTED THAT DURING A ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGERY, WHILE USING THE HEALIX ADVANCE DEVICE THE ANCHOR WAS INSERTED INTO THE BONE, THE ANCHOR BROKE PARTWAY THROUGH INSERTION. THERE WERE NO PIECES REMAINING IN THE BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25523761 ↗MalfunctionJun 10, 2026Difficult to Advance
IT WAS REPORTED THAT DURING ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION FOR ROTATOR CUFF TEAR, THE HEALIX ADVANCE WAS USED ACCORDING TO THE PROCEDURE MANUAL, BUT THE ANCHOR WAS NOT FIXED AND DISLODGED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF UNDER 30 MINUTES AND NO HARM TO THE PATIENT. IT WAS CONFIRMED THAT THERE WERE NO REMAINING IMPLANTS IN THE BODY. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25460250 ↗MalfunctionJun 9, 2026Difficult to Advance
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR FOR A ROTATOR CUFF TEAR, THE HEALIX ADVANCE WAS USED ACCORDING TO THE PROCEDURE MANUAL, BUT THE ANCHOR WAS NOT FIXED AND DISLODGED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS SURGICAL DELAY OF UNDER 30 MINUTES AND NO HARM TO THE PATIENT. IT WAS CONFIRMED THAT THERE WERE NO REMAINING IMPLANTS IN THE BODY. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25447969 ↗MalfunctionJun 8, 2026Mechanical Jam
THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, WHILE USING 2X HEALIX ADVANCE DEVICES, WHEN THE SURGEON TRIED TO REMOVE THE DILATOR FIXATION SUTURE FROM THE STUMP OF THE IMPLANT SHAFT AFTER PLACING THE ANCHOR, IT WAS FOUND THAT THE SUTURE WAS STUCK INSIDE THE STUMP AND COULD NOT BE REMOVED WITHOUT USING A KOCHER TOOL. THE SUTURE WAS REMOVED WITH A KOCHER TOOL AND RELEASED FROM THE SHAFT BEFORE USE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25430011 ↗MalfunctionJun 8, 2026Mechanical Jam
THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, WHILE USING 2X HEALIX ADVANCE DEVICES, WHEN THE SURGEON TRIED TO REMOVE THE DILATOR FIXATION SUTURE FROM THE STUMP OF THE IMPLANT SHAFT AFTER PLACING THE ANCHOR, IT WAS FOUND THAT THE SUTURE WAS STUCK INSIDE THE STUMP AND COULD NOT BE REMOVED WITHOUT USING A KOCHER TOOL. THE SUTURE WAS REMOVED WITH A KOCHER TOOL AND RELEASED FROM THE SHAFT BEFORE USE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25428056 ↗MalfunctionJun 1, 2026Crack
IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE 4.75 HEALIX ADVANCE KNTLS BR ANCHOR DEVICE CRACKED WHEN LOADING SUTURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350606 ↗MalfunctionMay 28, 2026Crack
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE BONE FRACTURED DURING INSERTION OF A 6.5MM HEALX ADV SP BIOC ANCHOR DUE TO VERY SOFT BONE. ANOTHER ANCHOR FROM A DIFFERENT WAS USED AND FUNCTIONED NORMALLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. THE SURGEON CONFIRMED THAT NO RESIDUE REMAINED IN THE BODY AND THERE WAS NO IMPACT ON THE PATIENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25318252 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6). STUDY NO: (B)(6). POST MARKET COMPLICATION RECEIVED FOR RE-TEARS OR NEW TEARS (LEFT KNEE DISPLACED BUCKET HANDLE MEDIAL MENISCUS TEAR). DATE OF EVENT: (B)(6) 2025. DATE OF IMPLANT: (B)(6) 2023 (LEFT ACL TEAR, MEDIAL MENISCUS TEAR, LATERAL MENISCUS TEAR). DATE OF REOPERATION/REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: RE-OPERATION WITH NO IMPLANT REMOVED/IMPLANTED DEPUY SYNTHES PRODUCTS USED: RGDLOOP ADJUSTABLE LONG: CATALOG NUMBER: 232448. LOT NUMBER: 8L67308. DEPUY SYNTHES PRODUCTS USED: TRUESPAN 12 DEGREE PEEK: CATALOG NUMBER: 228151. LOT NUMBER: 9L71051. DEPUY SYNTHES PRODUCTS USED: INTRAFIX ADVANCE 10X23 SCREW & LARGE 23MM SHEATH. CATALOG NUMBER: 254803. LOT NUMBER: 9L62950. DEPUY SYNTHES PRODUCTS USED: 5.5MM HEALIX ADVANCE SP BIOCOMPOSITE ANCHOR. CATALOG NUMBER:222424. LOT NUMBER: 116L683. REPORT 4 OF 4 FOR (B)(4).
Patient problems: Unspecified Tissue Injury
MAUDE report 25301070 ↗MalfunctionMay 26, 2026Break; Migration
IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE 4.9MM HEALX ADV SP BIOC ANCHOR DEVICE BROKE CAUSING THE PEAK TO BE PULLED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25285827 ↗
Other Medos International Sàrl products
- TRUESPAN ORTHOCORD6 models · 4,109 reports
- FMS39 models · 3,588 reports
- EXPEDIUM291 models · 3,312 reports
- EXPEDIUM VERSE90 models · 2,686 reports
- EXPRESSEW6 models · 2,459 reports
- OMNISPAN ORTHOCORD3 models · 1,581 reports
- HEALIX ADVANCE ORTHOCORD21 models · 1,311 reports
- PROWLER SELECT9 models · 1,066 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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