MAUDE Adverse Event Report: STRYKER GMBH GLENOSPHERE HOLDER/ IMPA CTOR; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5901-1168
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that during a primary right reverse shoulder procedure, the glenosphere impactor threaded tip broke off in the implant in impaction.The broken pieces were removed and a backup device was used to finish the case.
Additional Manufacturer Narrative
D9 / h3 updated to indicate the device was not returned.The reported event could not be confirmed, since the device was not returned.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.The operative technique was previously revised to emphasise the importance of having a good connection between the two parts.Op tech was updated with a statement that clearly describes the full engagement of glenosphere holder/impactor and glenosphere to eliminate any spaces and movement of glenosphere impactor/ holder.An nc and a capa were opened to rework the design of the device to avoid further breakages of the tip.A review of the device history was not possible because the lot number was not communicated.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 was not returned.
Event or Problem Description
It was reported that during a primary right reverse shoulder procedure, the glenosphere impactor threaded tip broke off in the implant in impaction.The broken pieces were removed and a backup device was used to finish the case.

• Brand Name: GLENOSPHERE HOLDER/ IMPA CTOR
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11728971
• Report Number: 0008031020-2021-00180
• Device Sequence Number: 3946680
• Product Code: KWS
• UDI-Device Identifier: 07613327101027
• UDI-Public: 07613327101027
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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: 5901-1168
• Device Catalogue Number: 5901-1168
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1