MAUDE Adverse Event Report: STRYKER GMBH ONE-THIRD TUBULAR PLATE VARIAX2 6 HOLE / L71MM; PLATE, FIXATION, BONE

Catalog Number	626676
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device anticipated to be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
Broken plate had to be replaced.Update from rep 6/14/18 mg: the first surgery was successful the patient broke the plate at home and the surgeon brought him back to put a new plate on.
Event or Problem Description
Broken plate had to be replaced.Update from rep 6/14/18 mg: the first surgery was successful the patient broke the plate at home and the surgeon brought him back to put a new plate on.
Additional Manufacturer Narrative
The reported event that one-third tubular plate variax2 6 hole/l71mm was alleged of 'implant breakage after surgery' could be confirmed.Based on investigation, the root cause was attributed to be patient related.The failure was caused by overload (fatigue breakage).Microscopic investigation revealed that the fracture surface had suffered severe secondary damage.Evidence of microscopic vibration fracture characteristics was found on the fracture surface.Based on the results of the examination, it can be stated that the plate failed due to a vibration (fatigue) fracture.The breakage of the plate occurred 6 weeks after implantation.Plate can break when patient is obese or when patient does not respect postoperative care or when patient keeps an important activity within 6 weeks after surgery.All of these reasons could not be excluded in this case: no information has been provided regarding patient postoperative care.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 any further information is provided, the investigation report will be updated.

• Brand Name: ONE-THIRD TUBULAR PLATE VARIAX2 6 HOLE / L71MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7627167
• Report Number: 0008031020-2018-00473
• Device Sequence Number: 1818879
• Product Code: HRS
• UDI-Device Identifier: 07613327088724
• UDI-Public: 07613327088724
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K151879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018

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 Catalogue Number: 626676
• Device Lot Number: V48203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 10/31/2018
• 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
• Patient Age: 42 YR