MAUDE Adverse Event Report: STRYKER GMBH CENTER SCREW T25 DRIVER; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5901-1122
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Device disposition is unknown.
Event or Problem Description
It was reported that hospital staff gave the rep a t25 screwdriver with a broken tip and reported it had broken on (b)(6) 2019 during a reverse shoulder procedure.Rep was not present for the procedure and confirmed that no further information is available.
Additional Manufacturer Narrative
Correction: refer to d10/h3.The reported event could be confirmed.The device inspection revealed the following: the tip of the returned screwdriver is indeed completely broken / snapped off during the reverse shoulder procedure (cracks are visible).The instrument as such looks clearly worn and therefore has been surely often used despite its age (as indicated).The close up views, done by the microscope, indicating though that the surface of the breakage is homogenous which again indicate conformity to the given specification.Whereas high applied forces led to a strain of the material which finally resulted in the breakage during the reverse shoulder procedure.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 investigation, the root cause was attributed to be user related.The failure was caused by repeated powerful dynamically overload during use.If any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported that hospital staff gave the rep a t25 screwdriver with a broken tip and reported it had broken on (b)(6) 2019 during a reverse shoulder procedure.Rep was not present for the procedure and confirmed that no further information is available.

• Brand Name: CENTER SCREW T25 DRIVER
• 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: 9387542
• Report Number: 0008031020-2019-01987
• Device Sequence Number: 470273
• Product Code: KWS
• UDI-Device Identifier: 07613327100303
• UDI-Public: 07613327100303
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• 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): 02/03/2020

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 Model Number: 5901-1122
• Device Catalogue Number: 5901-1122
• Device Lot Number: SC25650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1