NA 219024Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705005390), received between Jul 2, 2018 and Nov 19, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (2 reports).

1 FDA recall record name this device's identifier.

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 16, 2026.

Recalls naming this device

1. Aug 30, 2018Terminated

   The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole.

   Z-0208-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2018Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE SALES REP'S SCREW/WASHER DEPTH GAUGE HAD AN INCORRECT MEASUREMENT. THE SALES REP STATED THAT THEY MEASURED WITH THE DEPTH GAUGE, DRILLED THE HOLE IN THE PATIENT, AND INSERTED THE APPROPRIATE SCREW FOR THE SIZE HOLE THAT WAS DRILLED, HOWEVER THE SCREW WAS TOO SHORT AND THE SALES REP STATED THE CASE WAS DELAYED TWENTY-FIVE MINUTES AS THEY ATTEMPTED TO FIND THE APPROPRIATELY SIZED SCREW. THE CASE WAS COMPLETED WITH A LONGER SCREW IN THE SAME BONE HOLE. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE. THE DEVICE IS BEING RETURNED FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 8084221 ↗
• MalfunctionAug 6, 2018Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT BEFORE AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEPTH GAUGE SCREW & WASHER SYSTEM WAS NOT WORKING PROPERLY. THE CUSTOMER HAD LIMITED INFORMATION, BUT REPORTED THAT THE PIECE THAT SLIDES IN AND OUT OF THE GAUGE WAS WHAT APPEARED TO BE BROKEN. THE CUSTOMER REPORTED THAT A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO CONSEQUENCES. THE CUSTOMER WILL BE SENDING THE DEVICE BACK TO THE LAB SO A PRODUCT EVALUATION MAY BE CONDUCTED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7752384 ↗
• MalfunctionJul 17, 2018Imprecision; Imprecision

  IT WAS REPORTED VIA EMAIL BY THE SALES REP THAT HIS N/C REPLACEMENT DEVICE HAS THE SAME FAILURE AS HIS ORIGINAL COMPLAINT ((B)(4)) WHICH WAS THE CUSTOMER'S DEPTH GAUGE IS MEASURING 4-5MM INCORRECTLY. SALES REP PROVIDED A PHOTO. THIS DEVICE IS BEING RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7694202 ↗
• MalfunctionJul 2, 2018Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED BY THE SALES REP VIA PHONE DURING AN EPFL RECONSTRUCTION PROCEDURE THE CUSTOMER'S DEPTH GAUGE SCREW & WASHER SYSTEM 20M-80MM IS READING INACCURATE BY 6MM. THE SALES REP STATED THAT THE SURGEON WAS REALLY UPSET ABOUT THE ISSUE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE FROM A SYNTHES TRAY WITH NO HARM TO THE PATIENT BUT THERE WAS A 15 MINUTE DELAY TO GRAB THE OTHER TRAY. THE SALES REP STATED THAT THERE WAS NO LOT NUMBER ON THE DEVICE. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7655215 ↗