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	02/08/2021
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 while positioning the glenosphere, the threaded tip of the inserter broke off in the glenosphere.Rep confirmed there was no use of a mallet on the inserter.Surgeon was able to remove the threaded portion, and the surgery was completed successfully with a delay of approximately 5-10 minutes.
Event or Problem Description
Primary procedure, right reverse total shoulder.It was reported that while positioning the glenosphere, the threaded tip of the inserter broke off in the glenosphere.Rep confirmed there was no use of a mallet on the inserter.Surgeon was able to remove the threaded portion, and the surgery was completed successfully with a delay of approximately 5-10 minutes.
Additional Manufacturer Narrative
The reported event could be confirmed.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 with the fact that the impactor was not fully engaged/ not in alignment to the glenosphere.In this regard, 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.A further corrective action report was opened to revise the design of the device, to prevent further breakages.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 ; SZ 2545
• MDR Report Key: 11404930
• Report Number: 0008031020-2021-00076
• Device Sequence Number: 4502675
• Product Code: KWS
• UDI-Device Identifier: 07613327101027
• UDI-Public: 07613327101027
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/04/2021

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: 03/02/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR