MAUDE Adverse Event Report: STRYKER GMBH HOOK PLATE VARIAX CLAVICLE 6 HOLE / 16MM / LEFT; PLATE, FIXATION, BONE

Catalog Number	628526S
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Not available.
Event or Problem Description
Fixed shoulder joint dislocation with the variax plate on may 31.As the hook tip bites into the shoulder peak gradually, it leads to removal before completely cutting out.It pulled out on october 18th.
Additional Manufacturer Narrative
The reported event that hook plate variax clavicle 6 hole / 16mm / left was alleged of 'migration / rotation / in situ mouvement' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event such as pre- and post- operative x-rays, as well as the affected device must be available in order to determine the root cause of the complaint event.It is important to receive this kind of information in order to assess if the size of the implant used was adequate, if the implant was placed properly, to understand the exact indication that the implant was supposed to treat.Etc.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
Fixed shoulder joint dislocation with the variax plate on may 31.As the hook tip bites into the shoulder peak gradually, it leads to removal before completely cutting out.It pulled out on october 18th.

• Brand Name: HOOK PLATE VARIAX CLAVICLE 6 HOLE / 16MM / LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8075003
• Report Number: 0008031020-2018-00979
• Device Sequence Number: 14044444
• Product Code: HRS
• UDI-Device Identifier: 07613327085549
• UDI-Public: 07613327085549
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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 Expiration Date: 10/31/2022
• Device Catalogue Number: 628526S
• Device Lot Number: L48118
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 01/18/2019
• 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