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

Catalog Number 5901-1168

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

Tip of glenoid / holder impactor broken while surgeon tried to detach.Broken piece was left in the implant.No further information is available.

Manufacturer Narrative

The reported event could be confirmed.The device inspection revealed the following: the threaded front section of the glenosphere holder - piston is indeed completely broken off.The broken surface is smooth 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.No marks of corrosion can be noticed though.Hammer marks on the striking surface are clearly visible but as expected.A review of the device history for the reported lot did not indicate any abnormalities.However, due to multiple impactor breakages, a non-conformity has been raised for further investigation of the multiple events.No further action 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.Based on investigation, the root cause was attributed to be user related.The failure was caused by an inadequate engagement of the glenospehere holder/impactor, which caused a misalignment of the device, and thus the breakage of the impactor.If any further information is provided, the investigation report will be updated.

Event Description

Tip of glenoid / holder impactor broken while surgeon tried to detach.Broken piece was left in the implant.No further information is available.

• Brand Name: GLENOSPHERE HOLDER/ IMPA CTOR
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9226592
• MDR Text Key: 193310397
• Report Number: 0008031020-2019-01504
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327101027
• UDI-Public: 07613327101027
• Combination Product (y/n): N
• PMA/PMN Number: K130895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5901-1168
• Device Lot Number: P18N20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR