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

Model Number	5901-1122
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/15/2022
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 surgeon was using the center screw t25 driver on a large t handle putting the center screw into the baseplate.While turning the center screw t25 driver the tip of the screw driver broke off in the central screw.The surgeon attempted to remove the tip of the screw driver, but it was fixated in the central screw.The surgeon then continued with the surgery and impacted the glenosphere.The center screw t25 driver was no longer needed to complete the surgery and was removed from the consignment set at (b)(6).
Additional Manufacturer Narrative
Please note correction to d9/h3 as the device was not returned for evaluation.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.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 the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.
Event or Problem Description
It was reported that the surgeon was using the center screw t25 driver on a large t handle putting the center screw into the baseplate.While turning the center screw t25 driver the tip of the screw driver broke off in the central screw.The surgeon attempted to remove the tip of the screw driver, but it was fixated in the central screw.The surgeon then continued with the surgery and impacted the glenosphere.The center screw t25 driver was no longer needed to complete the surgery and was removed from the consignment set at (b)(6).

• 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 ; SZ 2545
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14317289
• Report Number: 0008031020-2022-00225
• Device Sequence Number: 4794933
• Product Code: KWS
• UDI-Device Identifier: 07613327100303
• UDI-Public: 07613327100303
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/09/2022

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: SC10636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2013
• 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