RESTORE 219321Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886705005727), received between Jul 11, 2018 and Mar 6, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Material Deformation

  IT WAS REPORTED THAT THE ACL DRILLPN W/EYE .094X14 DEVICE AND RIGIDLOOP REAMER 4.5MM DEVICE WERE DEFECTIVE; BENT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WERE NO REPORTS OF SURGICAL DELAY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24534749 ↗
• MalfunctionFeb 28, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION (RIGHT KNEE) SURGICAL PROCEDURE WHILE USING THE TWISTR ACL DISPOSABLES KIT DEVICE A DRILL TIP PASSING PIN BROKE WHILE LOADED ON POWER AND ADVANCING FROM THE TIBIA INTO THE FEMUR (TRANSTIBIAL APPROACH). THE TIP OF THE DRILL PIN BROKE OFF AND IS CONTAINED WITHIN THE CORTICAL BONE OF THE FEMUR. THE SURGEON DECIDED TO LEAVE THE METAL FRAGMENT SINCE IT WAS CONTAINED IN THE BONE. THE PASSING PIN WAS BENT ONCE REMOVED FROM THE KNEE. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT A TIME DELAY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21496597 ↗
• MalfunctionJul 3, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WAS DIRTY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19667363 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL FROM FRANCE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ACL RESTORE DRILL POINT PIN WITH EYELET .094 X 14 INCHES (2.39MM X 35.6CM) DEVICE BROKE AND REMAINED IN THE PATIENT'S BONE VISIBLE ON THE X-RAY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS NOT REPORTED IF THERE WAS PATIENT CONSEQUENCES OR PROLONGED HOSPITALIZATION REQUIRED AS A RESULT OF THIS EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18970413 ↗
• MalfunctionAug 3, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN FRANCE THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, A DRILL PIN W/EYELET .094X14 DEVICE WAS USED. ACCORDING TO THE REPORT, THE THREADED END ON THE DEVICE BROKE OFF AT THE TIBIAL TUNNEL; AND BECAME LODGED IN THE PATIENT'S DIAPHYSEAL SHAFT. IT WAS REPORTED THAT THE SURGEON DECIDED TO LEAVE THE METAL FRAGMENT IN THE PATIENT'S BONE. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17452593 ↗
• MalfunctionJan 25, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 2.4 MM X 15" CALIBRATED PASSING PIN WITH DRILL TIP DEVICE BROKE WHILE PUSHING IT THROUGH A BENT FEMORAL AIMER. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16243238 ↗
• InjurySep 14, 2020Material Deformation; Material Deformation

  IT WAS REPORTED FROM (B)(6) THAT DURING A KNEE LIGAMENTOPLASTY SURGERY ON (B)(6) 2020, IT WAS OBSERVED THAT THE HAND DRILL DEVICE WAS TWISTED WHILE THE PATIENT WAS ASLEEP. DUE TO THIS EVENT, THE PROCEDURE WAS STOPPED AND THE PATIENT AWOKE. THE SURGERY WAS RESCHEDULED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10527696 ↗
• MalfunctionFeb 28, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED VIA THE AFFILIATE THAT BEFORE AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION REPAIR ON 2 OF THE ACL DRILLPN W/EYE .094X14" EA WERE MISMATCHING WITH THE LABELS ON THE PACKAGE. NO PATIENT CONSEQUENCE, AND NO SURGICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771692 ↗
• MalfunctionFeb 28, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED VIA THE AFFILIATE THAT BEFORE AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION REPAIR ON 2 OF THE ACL DRILLPN W/EYE .094X14" EA WERE MISMATCHING WITH THE LABELS ON THE PACKAGE. NO PATIENT CONSEQUENCE, AND NO SURGICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771472 ↗
• MalfunctionFeb 6, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY AFFILIATE VIA PERSONAL INTERACTION, THAT PRE-OPERATIVELY TO AN ACLR THE FOLLOWING LOT # MISMATCHING WERE FOUND BETWEEN ACTUAL DRILL PINS (219321) AND LABELS ON RESPECTIVE PACKAGE. 1. DRILL PIN WITH ETCHED LOT #1905009: LOT #1906526 WAS PRINTED ON THE LABEL. 2. DRILL PIN WITH ETCHED LOT # 1905012: LOT #1906574 WAS PRINTED ON THE LABEL. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9677546 ↗
• MalfunctionFeb 6, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY AFFILIATE VIA PERSONAL INTERACTION, THAT PRE-OPERATIVELY TO AN ACLR THE FOLLOWING LOT # MISMATCHINGS WERE FOUND BETWEEN ACTUAL DRILL PINS (219321) AND LABELS ON RESPECTIVE PACKAGE. DRILL PIN WITH ETCHED LOT #1905009: LOT #1906526 WAS PRINTED ON THE LABEL. DRILL PIN WITH ETCHED LOT #1905012: LOT #1906574 WAS PRINTED ON THE LABEL. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9677257 ↗
• InjuryMay 30, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) VIA FAX THAT DURING A KNEE LIGAMENTOPLASTY WHEN CARRYING THE PATIENT'S LIGAMENT, THE SURGEON DISCOVERED THAT THE EXTREMITY OF THE ACL DRILL PIN WITH EYELET WAS BROKEN. THE X-RAYS CONFIRMED THE PRESENCE OF THE BROKEN PIECE AT THE END OF THE FEMORAL TUNNEL. THE FRAGMENT WAS NOT EXTRACTED AND REMAINED INSIDE THE PATIENT'S KNEE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WAS A PROLONGED HOSPITALIZATION. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8655460 ↗
• MalfunctionJan 30, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED DURING AN UNKNOWN PROCEDURE THE ACR DRILLPN W/EYE AND THE CRUCIATE + BEATH PIN BULLET BECAME STUCK TOGETHER. THE DEVICES BECAME STUCK WHILE DRILLING THE TIBIAL TUNNEL. THE PROCEDURE WAS COMPLETED USING A BACK-UP TRAY. THERE WAS 39-SECOND DELAY IN SURGERY AND NO PATIENT CONSEQUENCE. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8290060 ↗
• MalfunctionJul 11, 2018Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING PRE-SURGERY INSPECTION AT THE WAREHOUSE, IT WAS OBSERVED THAT THE DRILL POINT PIN DEVICE WAS BROKEN INSIDE THE RATCHET GUIDE DEVICE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7677655 ↗