MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 10 HOLE / LEFT; PLATE, FIXATION, BONE

Catalog Number	628010S
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/25/2018
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.Device remains implanted.
Event or Problem Description
Operation of variaxclavicle on (b)(6).After 1 week, the distal screw is pulled out of the bone and the plate floats.It is unknown whether locked between the plate and the screw.Patient with poor compliance, even after the operation, rest was not maintained and the affected part was moved and the plate deviated.There is considering revision.
Additional Manufacturer Narrative
The reported event that superior plate - decreased curvature variax clavicle 10 hole/left was alleged of 'component loosened' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.No further detailed information available due to hospital policy.Based on investigation, the root cause was attributed to be patient related.The failure was caused as ¿the patient did not keep the doctor's attention and could not be rested.Nefertheless more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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
Operation of variaxclavicle on (b)(6).After 1 week, the distal screw is pulled out of the bone and the plate floats.It is unknown whether locked between the plate and the screw.Patient with poor compliance, even after the operation, rest was not maintained and the affected part was moved and the plate deviated.There is considering revision.

• Brand Name: SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 10 HOLE / LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7531479
• Report Number: 0008031020-2018-00376
• Device Sequence Number: 1718973
• Product Code: HRS
• UDI-Device Identifier: 04546540686886
• UDI-Public: 04546540686886
• Combination Product (Y/N): N
• PMA/510(K) Number: K113760
• 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): 06/28/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 628010S
• Device Lot Number: L43087
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/28/2018
• 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: Required Intervention