MAUDE Adverse Event Report: STRYKER GMBH SR 4MM OFFSET HUMERAL HE AD TRIAL 44X22; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	5901-E-4422
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2017
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
It was reported that while performing a total right shoulder procedure, the post on the trial reduction broke.Surgeon retrieved the post and visually confirmed that no pieces were left inside patient.
Additional Manufacturer Narrative
Evaluation revealed the sr 4mm offset humeral head trial 44x22 to be the subject product.No further associated products were reported.A physical examination could not be carried out as the item was not received for evaluation.Thus a reasonable examination and investigation was not possible.A review of the device history records revealed no discrepancies.During investigation no material, design or manufacturing related issues were found.With the information given the reported event could not be confirmed or reproduced.A more precise evaluation was not possible.With available information a deficiency of the device could not be verified.The file will be closed formally.In case the item should become available the investigation will be reopened.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject products.No non-conformity was identified.Device was not returned.
Event or Problem Description
It was reported that while performing a total right shoulder procedure, the post on the trial reduction broke.Surgeon retrieved the post and visually confirmed that no pieces were left inside patient.

• Brand Name: SR 4MM OFFSET HUMERAL HE AD TRIAL 44X22
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7069105
• Report Number: 0008031020-2017-00675
• Device Sequence Number: 799762
• Product Code: LXH
• UDI-Device Identifier: 07613327099843
• UDI-Public: 07613327099843
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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): 01/19/2018

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: Health Professional
• Device Catalogue Number: 5901-E-4422
• Device Lot Number: MAC6K09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 01/19/2018
• 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
• Patient Age: 74 YR
• Patient Weight: 107