MAUDE Adverse Event Report: STRYKER GMBH DISTAL POSTERIOR LATERAL HUMERUS PLATE VARIAX FOR LEFT HUMERUS 6 HOLE / L128M; PLATE, FIXATION, BONE

Catalog Number	629246
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that the patient's left distal humerus was revised.The proximal end of the plate pulled off the bone.Three screw heads passed through the holes in the plate and remained in the bone.Surgeon reported that no trauma had taken place prior to revision.
Additional Manufacturer Narrative
The reported event could be confirmed based on the provided x-rays as well as the returned device.The device inspection revealed the following: severe rupture at 3 screw holes where bone screws were inserted into the plate.The screw holes were ruptured inwards consistent with the result of forced entry through the plate screw holes by the screw head.The hexagonal inserts on the 3 screw heads also showed reasonable damage consistent with mis-alignment of screwdriver head during screw insertion or extraction.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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by application of excessive load on the implant or trauma.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the patient's left distal humerus was revised.The proximal end of the plate pulled off the bone.Three screw heads passed through the holes in the plate and remained in the bone.Surgeon reported that no trauma had taken place prior to revision.

• Brand Name: DISTAL POSTERIOR LATERAL HUMERUS PLATE VARIAX FOR LEFT HUMERUS 6 HOLE / L128M
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8914881
• Report Number: 0008031020-2019-01091
• Device Sequence Number: 13953302
• Product Code: HRS
• UDI-Device Identifier: 07613154970575
• UDI-Public: 07613154970575
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K101056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

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: Lay User/Patient
• Device Catalogue Number: 629246
• Device Lot Number: J07266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 10/04/2019
• 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: Required Intervention
• Patient Age: 29 YR