Arthrex® AR-7292Recalls & reported problems
Arthrex, Inc. · SuturePatch Trapezoid, 45 x 35mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867301962), received between Sep 18, 2026 and Sep 18, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem2
Patient problems
- Foreign Body Reaction2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Patient Device Interaction Problem
On 16 September 2026, it was reported by a Sales Representative via email that an AR-7292, SuturePatch Trapezoid 45 x 35mm was reported to have the patient treated for a large rotator cuff repair using fibertak medial and push locks lateral. the patient was augmented using a suturepatch and fixed with fiberstitch 1.5mm medial. Following the repair, which was successful, the patient presented with welts on outer skin and redness around the incision sites. upon further investigation, the patients joint was inflamed and there was a response. The patient was re-operated on (b)(6) 2026 where the patch was removed and debrided. This occurred on (b)(6) 2026 during a RCR Cuff repair and Augmentation with Suture Patch Procedure. The case was completed successfully re-operating to remove the patch. There was case involvement.
Patient problems: Foreign Body Reaction
MAUDE report 50818271 ↗InjurySep 18, 2026Patient Device Interaction Problem
On 16 September 2026, it was reported by a Sales Representative via email that an AR-7292, SuturePatch Trapezoid 45 x 35mm was reported to have the case done on (b)(6). Large Rotator Cuff Repair, FiberTak 2.6mm Medial, into 3.5mm Pushlock Laterally. The Cuff was augmented with a Suture Patch graft and fixated with Fiber stitch 1.5mm in an all-arthroscopic repair. The patient presented with an inflammatory response 3 months post op and was reoperated on (b)(6) 2026 to debride and clean out. Biopsy was taken and the report showed an immune reaction not and infection. This occurred on (b)(6) 2026 during a Rotator Cuff Repair Procedure. The case was completed successfully. There was case involvement.
Patient problems: Foreign Body Reaction
MAUDE report 50818142 ↗
Other Mesh, surgical, non-absorbable, orthopaedics, reinforcement of tendon devices
- Integrity Implant 6000101Anika Therapeutics, Inc. · Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon6 reports
- Integrity Implant 6000100Anika Therapeutics, Inc. · Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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