MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR LATERAL PLATE VARIAX CLAVICLE 7 HOLE / RIGHT; PLATE, FIXATION, BONE

Catalog Number	628227S
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/09/2018
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 is not available.
Event or Problem Description
It was reported that the orif was done with variax clavicle plate at (b)(6) 2017.Over one year after operation, he fractured again when he supported 750cc bike.The plate was bent to 45 degree and screws back out and broken was not occurred.All devices were removed and reduce fracture bone and the plate was re-implanted.
Event or Problem Description
It was reported that the orif was done with variax clavicle plate at (b)(6)2019.Over one year after operation, he fractured again when he supported 750cc bike.The plate was bent to 45° and screws back out and broken was not occurred.All devices were removed and reduce fracture bone and the plate was re-implanted.
Additional Manufacturer Narrative
The reported event that superior lateral plate variax clavicle 7 hole / right was alleged of 'bone damaged' could be confirmed only according to the provided pictures and x-rays though.Based on investigation, the root cause was attributed to be patient related.The failure was caused by too much mechanical force as the patient lifted / supported his 750cc bike.The sent pictures and x-rays revealed the following: the plate is indeed very badly bent (just above the broken bone) as the lifting / supporting of the patients heavy 750cc bike surely exceeded the mechanical capacity of the plate.Unfortunately it is not clearly evident to which extend the screws were backing out.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.

• Brand Name: SUPERIOR LATERAL PLATE VARIAX CLAVICLE 7 HOLE / RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8139807
• Report Number: 0008031020-2018-01028
• Device Sequence Number: 1106652
• Product Code: HRS
• UDI-Device Identifier: 04546540687135
• UDI-Public: 04546540687135
• Combination Product (Y/N): N
• PMA/510(K) Number: K113760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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: 02/28/2022
• Device Catalogue Number: 628227S
• Device Lot Number: L10057
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 01/10/2019
• 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: 50 YR