PANALOK ETHIBOND 210026Recalls & reported problems
Depuy Mitek, LLC · PANALOK Absorbable Anchor 3.5mm Size 2 (5 metric) white ETHIBOND braided polyester suture, 36 Inches (91cm), double-armed with CP-2 needles, with disposable inserter. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705000814), received between May 29, 2020 and May 29, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
- Migration or Expulsion of Device1
Patient problems
- Foreign Body In Patient1
- Not Applicable1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2020Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device
IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING A SHOULDER REPAIR, A PANALOK #2 ETHIBOND GREEN CP-2 AND A PANALOK #2 ETHIBOND WHITE CP-2 EA, PRESENTED ISSUES. WHEN PLACING PANALOK HAD ONE ANCHOR PULL OUT AFTER INSERTION (STILL ATTACHED TO HANDLE). ON THE OTHER PANALOK ANCHOR, THE ANCHOR WAS INSERTED BUT THE METAL TIP OF THE INSERTER WAS BROKEN OFF. ONCE THEY NOTICED THE TIP WAS BROKEN THEY SPENT APPROXIMATELY 1 HOUR LOOKING FOR THE METAL PIECE. BROUGHT IN X-RAY TO CONFIRM THAT METAL TIP WAS IN SHOULDER BUT COULD NOT LOCATE. PROCEDURE WAS COMPLETED SUCCESSFULLY BUT THERE WAS A SURGICAL DELAY OF 60 MINUTES. NO PATIENT CONSEQUENCES REPORTED. DEVICES WERE DISCARDED.
Patient problems: Foreign Body In Patient; Not Applicable
MAUDE report 10101581 ↗
Other FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE devices
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- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 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 14, 2026 · each report above links to its original FDA record
- 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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