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	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2020
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
Primary procedure, right reverse shoulder.It was reported that while driving the central screw, the tip of the t25 driver broke in the screw.The tip was retrieved, device reassembled at back table, and patient was irrigated to ensure that all pieces were removed from the patient.A second driver which was already available in the o.R.Was used to complete the surgery successfully with no delay.Rep confirmed that no further information is available.
Additional Manufacturer Narrative
The reported event could be confirmed.The returned product matches the failure mode reported: the tip of the device is indeed broken.The torsional line that can be seen on the surface of the device reveal a breakage due of over-torque.The application of excessive force is therefore the root cause of the reported event.This case can be classified as user related.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
Primary procedure, right reverse shoulder.It was reported that while driving the central screw, the tip of the t25 driver broke in the screw.The tip was retrieved, device reassembled at back table, and patient was irrigated to ensure that all pieces were removed from the patient.A second driver which was already available in the operation room was used to complete the surgery successfully with no delay.Rep 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: 9786117
• Report Number: 0008031020-2020-00555
• Device Sequence Number: 714468
• 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): 05/13/2020

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: 03/11/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1