PERMALOOP 280937Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705032730), received between Sep 13, 2023 and Sep 15, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Detachment of Device or Device Component

  It was reported that during an unspecified surgical procedure it was observed that the PERMALOOP STRAIGHT NEEDLE device came off the tape while passing it through the bone tunnel of the bone-patellar tendon-bone (BTB) graft. The surgery was completed with no issues using another PERMALOOP device. There was no surgical delay and there was no harm to the patient. It was confirmed that there was no product remaining in the body. The surgeon stated that it might have been related to strong resistance due to attached soft tissue. No further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774312 ↗
• MalfunctionJul 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE FOR AN ACL YEAR, THE PERMALOOP STRAIGHT NEEDLE 1PK DEVICE WAS BEING USED WHEN THE NEEDLE SUDDENLY CAME OFF THE PERMALOOP WHEN THE DEVICE WAS BEING PASSED THROUGH THE GRAFT. THE SURGEON USED THE DEVICE PROPERLY; HENCE THE CAUSE OF THE EVENT WAS UNKNOWN. THERE WERE NO FOREIGN OBJECTS LEFT IN THE BODY. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22507279 ↗
• MalfunctionApr 23, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN THE PERMALOOP STRAIGHT NEEDLE SUTURE DEVICE PENETRATED THE TISSUE, IT FRAYED BADLY, RAISING CONCERNS ABOUT ITS STRENGTH, SO IT WAS REMOVED. IT WAS REPORTED THAT NO PART OF THE TAPE REMAINED IN THE BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY, WITH NO DIFFICULTY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891615 ↗
• MalfunctionMay 23, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED FROM JAPAN THAT DURING AN UNKNOWN PROCEDURE FOR ACL, IT WAS OBSERVED THAT WHEN THE PERMALOOP IN QUESTION WAS USED, THE ROTATOR CUFF WAS TORN. THERE WERE NO PIECES LEFT IN THE BODY. IT WAS REPORTED THAT A SPARE PERMALOOP WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19383833 ↗
• MalfunctionApr 25, 2024Migration; Migration

  REPORT 4 OF 4 FOR (B)(4) IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN UNSPECIFIED SURGERY FOR ANTERIOR CRUCIATE LIGAMENT ST SINGLE ON (B)(6) 2024, TWO PERMALOOP STRAIGHT NEEDLE 1PK DEVICES WERE USED PER GRAFT AND WHEN THE GRAFT WAS INSERTED INTO THE BONE HOLE, THE TENDON WAS TORN. IT WAS REPORTED THAT THEN, THE TWO TRUESPAN 12 DEGREE PLGA DEVICES ALSO CAME LOOSE. OTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19179152 ↗
• MalfunctionApr 25, 2024Migration; Migration

  REPORT 3 OF 4 FOR (B)(4) IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN UNSPECIFIED SURGERY FOR ANTERIOR CRUCIATE LIGAMENT ST SINGLE ON (B)(6) 2024, TWO PERMALOOP STRAIGHT NEEDLE 1PK DEVICES WERE USED PER GRAFT AND WHEN THE GRAFT WAS INSERTED INTO THE BONE HOLE, THE TENDON WAS TORN. IT WAS REPORTED THAT THEN, THE TWO TRUESPAN 12 DEGREE PLGA DEVICES ALSO CAME LOOSE. OTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19179150 ↗
• MalfunctionDec 19, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION (ACLR) PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SURGEON CUT THE DISTAL END OF THE LOOP WITH A POINTED BLADE AND PASSED THE PERMALOOP SUTURE BLUE BRAIDED TAPE LOOP STRAIGHT 31MM TAPER 1.3MM 20" (51CM) DEVICE INTO THE JOINT WITH THE STATE THAT IT HAD 2 SUTURE ENDS. AT THAT TIME, THE DISTAL PERMALOOP SNAPPED. WHEN PASSING SUTURES INTO THE JOINT, SOME TENSION IS APPLIED FROM THE TIBIA SIDE, BUT THE SURGEON SAID THAT THEY DID NOT APPLY ANY EXCESSIVE FORCE THAN NORMAL. THERE WAS ENOUGH LENGTH LEFT TO USE THE FIXATION DEVICE ¿DSP¿ ON THE TIBIA SIDE, SO THERE WAS NO PROBLEM WITH SUBSEQUENT PROCEDURES. THIS WAS A ACLR BY 2 ROUTES, AND ANOTHER PERMALOOP WITH THE SAME PRODUCT CODE WAS USED FOR THE OTHER ROUTE. IT WAS ABLE TO BE USED NORMALLY/SUCCESSFULLY. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. 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 18358623 ↗
• MalfunctionSep 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, AN UNKNOWN IMPLANT WAS USED FOR GRAFTING ANTERO-MEDIAL BUNDLE AND POSTERO-LATERAL BUNDLE. THE GRAFTS WERE SEMITENDINOSUS MUSCLE AND WERE FOLDED INTO 110 MM FOR POSTERO-LATERAL BUNDLE AND 130 MM FOR ANTERO-MEDIAL BUNDLE. THE BUNDLE THICKNESS WAS 5.0 MM FOR POSTERO-LATERAL BUNDLE AND 6.5 MM FOR ANTERO-MEDIAL BUNDLE. IT WAS REPORTED THAT THE GRAFTING ON THE POSTERO-LATERAL BUNDLE WAS DONE VERY NICELY. IT WAS REPORTED THAT TWO STITCHES ON THE UNKNOWN IMPLANT FOR THE ANTERO-MEDIAL BUNDLE CAME OFF WHEN THE SURGEON PULLED AND APPLIED A STRONG PRETENSION TO CHECK BEFORE GRAFT INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736547 ↗