MAUDE Adverse Event Report: STRYKER GMBH ANGLED DEPTH GAUGE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	703976
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the meter broke during the procedure.
Event or Problem Description
It was reported that the meter broke during the procedure.
Additional Manufacturer Narrative
Please note corrections to section d9/h3 the device was not returned.The received picture was reviewed, on the picture is an angled depth gauge in a tray visible.Not the complete gauge is visible and therefore a breakage cannot be confirmed.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.
Event or Problem Description
It was reported that the meter broke during the procedure.Update: no debris left in the patient's body.
Additional Manufacturer Narrative
Correction: d9/h3 the device was returned and h6 (method, results, conclusion, clinical signs and health impact codes).The reported event could be confirmed, since the depth gauge is broken as complained.Only the slider with the broken probe was returned for evaluation.The housing with the laser markings for the catalog- and lot number was not returned.The visual inspection has shown that the probe of the depth gauge is broken off at the crossover from the shaft to the probe in the area of the weld.The microscopic inspection of the fracture face has shown that the breakage started with a crack on one side due to fatigue caused by the applied lateral forces over the years (device manufactured in the year 2016).The rest of the surface has the typical view of a instantaneous fracture that occurred after the device was weakened by the initial crack.In general is the device in a very used condition, the shaft of the probe has different deformations and is much less bend as in the original condition.There are different discolorations, scratches and nicks all over the device.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on the investigation, the root cause was attributed to an user related issue.Wear and tear after often and intense use over the years in combination with a mechanical overload during use did lead to the breakage of the device.If any additional information is provided, the investigation will be reassessed.

• Brand Name: ANGLED DEPTH GAUGE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18737413
• Report Number: 0008031020-2024-00106
• Device Sequence Number: 7229367
• Product Code: LXH
• UDI-Device Identifier: 07613252731344
• UDI-Public: 07613252731344
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2024

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: 703976
• Device Lot Number: K066FB7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 03/21/2024; 06/06/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/16/2024; 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown