MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 TI FOR LEFT HUMERUS 3 HOLE / L86MM; PLATE, FIXATION, BONE

Model Number	627203S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
It was reported: for a fracture of the proximal right humerus, axsosph was scheduled to use at orif.While sterilizing the patient with general anesthesia, when the reporting sr was checking the implant, it was noticed that the left implant was arranged instead of the right one.So, the surgeon decided the operation to be suspended.The cause was the neglect of confirmation of the implant by the distributor and hospital.The implants were immediately arranged on the affected side, the operation was restarted 5 hours later, and the procedure completed successfully.Unnecessary general anesthesia.
Additional Manufacturer Narrative
The reported event that proximal lateral humerus plate axsos 3 ti for left humerus 3 hole / l86mm was alleged of issue ¿user related event - not product related¿ could be confirmed with the help of additional information provided through communication.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the provided info ¿it was noticed in the operating room before the operation.The cause was the neglect of confirmation of the implant by the distributor and hospital, not stryker japan.¿, the root cause of the failure is user related and not product related.If the device is returned or any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported: for a fracture of the proximal right humerus, axsosph was scheduled to use at orif.While sterilizing the patient with general anesthesia, when the reporting sr was checking the implant, it was noticed that the left implant was arranged instead of the right one.So, the surgeon decided the operation to be suspended.The cause was the neglect of confirmation of the implant by the distributor and hospital.The implants were immediately arranged on the affected side, the operation was restarted 5 hours later, and the procedure completed successfully.Unnecessary general anesthesia.

• Brand Name: PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 TI FOR LEFT HUMERUS 3 HOLE / L86MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10142719
• Report Number: 0008031020-2020-01586
• Device Sequence Number: 3468849
• Product Code: HRS
• UDI-Device Identifier: 07613327091038
• UDI-Public: 07613327091038
• Combination Product (Y/N): N
• PMA/510(K) Number: K181091
• 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): 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 627203S
• Device Catalogue Number: 627203S
• Device Lot Number: G15588
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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: 78 YR