MAUDE Adverse Event Report: STRYKER GMBH SR 4MM OFFSET HUMERAL HE AD TRIAL 52X20; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	5901-E-5220
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Upon incoming inspection, item was visibly worn.Both trials were missing inner plastic peg.No further information is available.
Additional Manufacturer Narrative
The reported event that sr humeral head trial 44 x19 was alleged of 'instruments - broken, deformed, worn or scratched' could be confirmed, since a picture of the device was send and the reported breakage could be noticed.Based on investigation, the root cause was attributed to the normal wear of the device after multiple years of use (in use since 2011).The cleaning and sterilization guide states: "note: stryker trauma & extremities typically does not specify the maximum number of uses appropriate for re-usable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.For devices that may be impacted check that the device is not damaged to the extent that it malfunctions or that burrs have been produced that could damage tissues or surgical gloves.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.The device inspection revealed the following: the device looks indeed worn and the some of the pags are broken.This can be attributed to normal wear of the device since it has been in use since 2011.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.Both trials were missing inner plastic peg.No further information is available.

• Brand Name: SR 4MM OFFSET HUMERAL HE AD TRIAL 52X20
• 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: 7930449
• Report Number: 0008031020-2018-00765
• Device Sequence Number: 14020631
• Product Code: KWS
• UDI-Device Identifier: 07613327099942
• UDI-Public: 07613327099942
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• 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,Followup
• Report Date (Section B): 11/29/2018

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-5220
• Device Lot Number: MAC6H13
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 11/29/2018
• 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