MAUDE Adverse Event Report: STRYKER GMBH GLENOSPHERE JACKSCREW; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5901-1184
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/30/2020
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 shoulder.It was reported that after impacting the glenosphere onto the baseplate, the glenosphere was off-angle.Surgeon inserted the jack screw to disengage the glenosphere.After the screw went in deeply, it snapped.The part of the screw outside the glenosphere was removed.After using other means to attempt to disengage the glenosphere, the surgeon reported the glenosphere was firmly fixed to the baseplate and used an impactor to adjust the glenoid to a better angle.After changing the angulation of the glenoid, the surgeon completed the procedure and was satisfied with the result.Surgery completed successfully with a delay of approximately 10 minutes.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the device is broken at the thread level.A microscope analysis shows that the fracture was due to a sudden significant torsional load on the material.The device probably broke after the application of an outstanding torsional force combined with some bending, while trying the remove the glenosphere.Based on investigation, the root cause was attributed to be user related.The failure was caused by too much force applied on the device.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 any further information is provided, the investigation report will be updated.
Event or Problem Description
Primary procedure, right reverse shoulder.It was reported that after impacting the glenosphere onto the baseplate, the glenosphere was off-angle.Surgeon inserted the jack screw to disengage the glenosphere.After the screw went in deeply, it snapped.The part of the screw outside the glenosphere was removed.After using other means to attempt to disengage the glenosphere, the surgeon reported the glenosphere was firmly fixed to the baseplate and used an impactor to adjust the glenoid to a better angle.After changing the angulation of the glenoid, the surgeon completed the procedure and was satisfied with the result.Surgery completed successfully with a delay of approximately 10 minutes.

• Brand Name: GLENOSPHERE JACKSCREW
• 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: 10329742
• Report Number: 0008031020-2020-01970
• Device Sequence Number: 2233902
• Product Code: KWS
• UDI-Device Identifier: 07613327100358
• UDI-Public: 07613327100358
• 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): 09/15/2020

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: 5901-1184
• Device Catalogue Number: 5901-1184
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR