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 Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; hospital retained.
Event or Problem Description
Primary procedure, left reverse shoulder.It was reported that upon impaction, the threaded portion of the glenosphere holder/ impactor broke off in the glenosphere.The threaded portion was removed and the surgery was completed successfully with no delay.Rep confirmed that no further information is available.
Additional Manufacturer Narrative
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.However, relative to this event, the operative technique emphasizes the importance of having a good connection between the two parts.Op tech includes a statement that describes the full engagement of glenosphere holder/impactor and glenosphere to eliminate any spaces and movement of glenosphere impactor/ holder.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.
Event or Problem Description
Primary procedure, left reverse shoulder.It was reported that upon impaction, the threaded portion of the glenosphere holder/ impactor broke off in the glenosphere.The threaded portion was removed and the surgery was completed successfully with no delay.Rep confirmed that no further information is available.

• 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 ; CH 2545
• MDR Report Key: 10286511
• Report Number: 0008031020-2020-01920
• Device Sequence Number: 13581951
• Product Code: KWS
• UDI-Device Identifier: 07613327101027
• UDI-Public: 07613327101027
• 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): 09/02/2020

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: 5901-1168
• Device Catalogue Number: 5901-1168
• Device Lot Number: P16E63
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1