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	01/07/2020
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
Primary procedure, left reverse shoulder.It was reported that upon impaction of the glenosphere, the threaded portion of the holder/ impactor broke off in the glenosphere.The broken threaded portion was able to be removed from the glenosphere and disposed.The procedure was completed successfully with no surgical delay.
Event or Problem Description
Primary procedure, left reverse shoulder.It was reported that upon impaction of the glenosphere, the threaded portion of the holder/ impactor broke off in the glenosphere.The broken threaded portion was able to be removed from the glenosphere and disposed.The procedure was completed successfully with no surgical delay.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the threaded front sections of the returned glenosphere holder ¿ piston is indeed completely broken off.The broken surface is finely fissured and the level fracture areas show a large shear lip at the edge of the surface.This is specific to a ductile fracture, which is caused by an excessive force applied on the device.The way the breakage occurred (on an angle) indicates this too.A review of the device history for the reported lot did not indicate any abnormalities.A non-conformity report had been opened in order to further investigate multiple similar breakages and address this issue for further details.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to be user related.The failure was caused by a possible inadequate engagement of the glenospehere holder/impactor, which caused a misalignment of the device, and thus the breakage of the impactor or simply too much force was applied (on an angle).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: 9659648
• Report Number: 0008031020-2020-00254
• Device Sequence Number: 319396
• 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): 04/01/2020

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: P18N20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR