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	05/27/2020
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 total shoulder.It was reported that on impaction, the threaded tip of the glenosphere impactor broke in the glenosphere.Surgeon reported he had been impacting at an angle due to patient anatomy.Glenosphere was brought to the back table, the threaded portion was removed.The long gray sleeve was removed from the impactor, and the broken impactor was used to complete the case successfully with a delay of approximately 10 minutes.The rep confirmed that no further information is available.
Event or Problem Description
Primary procedure, right reverse total shoulder.It was reported that on impaction, the threaded tip of the glenosphere impactor broke in the glenosphere.Surgeon reported he had been impacting at an angle due to patient anatomy.Glenosphere was brought to the back table, the threaded portion was removed.The long gray sleeve was removed from the impactor, and the broken impactor was used to complete the case successfully with a delay of approximately 10 minutes.The rep confirmed that no further information is available.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the reported event.During the investigation, the device inspection revealed the following: the tip of the glenosphere holder - piston shows a clean break of the tip towards the middle of the threaded area.The surface is finely fissured and the level fracture area shows shear lips at the edge of the surface.This is specific to a ductile fracture, which is caused by an excessive force applied on the device, most probably combined to the fact that the impactor was not fully engaged/ not in alignment to the glenosphere.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.

• 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: 10186682
• Report Number: 0008031020-2020-01754
• Device Sequence Number: 886191
• Product Code: KWS
• UDI-Device Identifier: 07613327101027
• UDI-Public: 07613327101027
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: P9S53
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 06/23/2020
• 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
• Patient Age: 63 YR