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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
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.
Event or Problem Description
As reported: "primary procedure, left reverse shoulder.It was reported that the threaded portion of the inserter broke off in the glenosphere.The implant was removed and a second implant was used to complete surgery successfully with a delay of approximately 30 minutes".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matches the reported event.The tip of the glenosphere impactor is indeed broken.The surface of the breakage shows a material deformation due to a sudden application of a high force.The toggling of the device during use is most probably the root cause of the breakage.However, this event was raised in the past, and two actions were taken on this catalog number: -the operative technique was previously revised to emphasise the importance of having a good connection between the two parts.The operative technique 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 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.
Event or Problem Description
A s reported: "primary procedure, left reverse shoulder.It was reported that the threaded portion of the inserter broke off in the glenosphere.The implant was removed and a second implant was used to complete surgery successfully with a delay of approximately 30 minutes.".

• 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: 11305292
• Report Number: 0008031020-2021-00038
• Device Sequence Number: 11067403
• Product Code: KWS
• UDI-Device Identifier: 07613327101027
• UDI-Public: 07613327101027
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/07/2021

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: P18N20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 04/07/2021
• 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