MAUDE Adverse Event Report: STRYKER GMBH DEPTH GAUGE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5901-1195
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2019
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
Upon incoming inspection, item was visibly worn.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause of the event is attributed to the normal wear of the device (it has been used since 2016) combined with an improper re-use by the users.The returned device shows traces of extensive re-cleaning/re-sterilization, since the color of the device is faded.Furthermore, the hook of the depth gauge has been disassembled from the ruler, which makes the device unusable.This proves that the instrument was not handled with the proper care it needed.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.If any further information is provided, the investigation report will be updated.
Event or Problem Description
Upon incoming inspection, item was visibly worn.

• Brand Name: DEPTH GAUGE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8621306
• Report Number: 0008031020-2019-00500
• Device Sequence Number: 16702623
• Product Code: KWS
• UDI-Device Identifier: 07613327100204
• UDI-Public: 07613327100204
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2019

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: 5901-1195
• Device Lot Number: AG12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 06/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1