MAUDE Adverse Event Report: STRYKER GMBH SR 4MM OFFSET HUMERAL HEAD TRIAL 44X19; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	5901-E-4419
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by misuse of the device as well as its natural wear (it has been used since 2011).Indeed, the device inspection shows that two of the 3 pegs are indeed broken.The surface of the breakage shows a sharp break, which proves that an important force was applied to the peg by the healthcare professional.As a reminder, the ifu clearly states: "avoid mechanical damage, e.G.Do not mix heavy devices with delicate ones." furthermore, the device has been in use since 2011.This extended period of use could have led to the natural wear of the instrument.The device inspection revealed the following: the device shows some traces of use due to the multiple years in the field.The event reported can be confirmed since 2 out of 3 pegs of the device are broken.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.
Event or Problem Description
Upon inspection it was noticed that the device was broken on underside of the device.

• Brand Name: SR 4MM OFFSET HUMERAL HEAD TRIAL 44X19
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8631242
• Report Number: 0008031020-2019-00509
• Device Sequence Number: 2016789
• Product Code: LXH
• UDI-Device Identifier: 07613327099874
• UDI-Public: 07613327099874
• 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): 05/22/2019

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: Health Professional
• Device Catalogue Number: 5901-E-4419
• Device Lot Number: MAC6K08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1