MAUDE Adverse Event Report: STRYKER GMBH DEPTH MEASURING GAUGE FOR SCREWS, LARGER THAN DIAM.1.7MM, MEA RANGE 27MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	62-10110
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that, after drilling, user measured the length with depth gage and attempted to insert the first screw, but the screw was too long.User then selected a size down screw, then continued selecting under size screws the same way and completed the procedure.The gage measurement was incorrect.No adverse consequences or surgical delay were reported.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and is fully functional.The device inspection revealed the following: visual inspection: the received depth measuring gauge shows wear.Functional inspection: the received depth measuring gauge set the scale to 10 (green arrow), and measure the distance between the two red arrows, it passed within the given tolerances.This is the first reported case with this lot number.Based on investigation, the root cause was attributed to a user related issue.Since the device is fully functional and conforming to specifications, the failure is not originally due to the device itself but due to current state of the device.The zero marker was found worn off due to repeated use of the gauge and frequent sterilization cycles.This led to surgeon not being able to take proper measurements.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that, after drilling, user measured the length with depth gage and attempted to insert the first screw, but the screw was too long.User then selected a size down screw, then continued selecting under size screws the same way and completed the procedure.The gage measurement was incorrect.No adverse consequences or surgical delay were reported.

• Brand Name: DEPTH MEASURING GAUGE FOR SCREWS, LARGER THAN DIAM.1.7MM, MEA RANGE 27MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8727047
• Report Number: 0008031020-2019-00718
• Device Sequence Number: 2572357
• Product Code: LXH
• UDI-Device Identifier: 04546540258212
• UDI-Public: 04546540258212
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 62-10110
• Device Lot Number: AB10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1