MAUDE Adverse Event Report: STRYKER GMBH SR 4MM OFFSET HUMERAL HE AD TRIAL 52X23; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	5901-E-5223
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event that sr 4mm offset humeral he ad trial 52x23 was alleged of 'instruments - broken, deformed, worn or scratched' could be confirmed.Based on investigation, the root cause was attributed to be other related.The failure was caused by to much applied mechanical force which this trial implant had to undergo over the years.The device inspection revealed the following: the entire three-jaw looking chuck is indeed completely broken at its base, making the device unusable.We do believe that to much applied mechanical force which this trial implant had to undergo over the years has finally resulted in the breakage of the three-jaw looking chuck.Note that this device was manufactured in may 2012 (wear and tear over the years).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
Upon incoming inspection, item was visibly worn.Investigation of the device revealed that the inner pegs were broken off and missing.

• Brand Name: SR 4MM OFFSET HUMERAL HE AD TRIAL 52X23
• Common Device Name: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8503031
• Report Number: 0008031020-2019-00352
• Device Sequence Number: 1783599
• Product Code: KWS
• UDI-Device Identifier: 07613327099928
• UDI-Public: 07613327099928
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/11/2019

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: Other
• Device Catalogue Number: 5901-E-5223
• Device Lot Number: MAC7K14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other