MAUDE Adverse Event Report: STRYKER GMBH WRIST FUSION PLATE STANDARD BEND VARIAX2 120MM; PLATE, FIXATION, BONE

Catalog Number	629579
Health Effect - Clinical Code	Rupture (2208)
Date of Event	07/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Patient reported feeling a pop when he was latching the boat on his hitch.The next morning after the pop, he could not lift his left index finger fully.He reports left wrist/ hand pain and swelling.X-ray (b)(6) 2018: fracture of left wrist arthrodesis plate at level of 3rd metacarpal base.No screw loosening.On (b)(6) 2018: hardware removed with failure at oblong hole".As listed under adverse consequences: "left index extensor tendon rupture".
Event or Problem Description
Patient reported feeling a pop when he was latching the boat on his hitch.The next morning after the pop, he could not lift his left index finger fully.He reports left wrist/ hand pain & swelling.X-ray (b)(6)2018: fracture of left wrist arthrodesis plate at level of 3rd metacarpal base.No screw loosening.(b)(6)2018: hardware removed with failure at oblong hole".As listed under adverse consequences: "left index extensor tendon rupture".
Additional Manufacturer Narrative
The reported event that wrist fusion plate standard bend variax2 120mm 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 5 months after implantation.The variax plate system is an internal fixation system which is intended fix the broken bone in a correct position or to perform an arthrodesis until sufficient bone consolidation is acchieved.The variax plating system is not intended to transmit full forces and bending moments of daily routine.Loading and weightbearing have to be individually reduced.Influence factors for the required load reduction are: the type of fracture or arthrodesis (e.G.Transverse fracture with sufficient bone support vs.Unstable comminuted fracture w/o sufficient bone contact), the localization of the fracture (e.G.Diaphysis vs.Metaphysis), the bone quality (e.G.Bone in younger patients vs.Osteoporotic bone), correct fracture reduction, correct fixation technique (e.G.Correct dimension of the plate, correct positioning of the plate, sufficient length of the plate, sufficient bending of the plate, correct screw placement with sufficient insertion torque).Depending on these individual influencing factors the attending physician has to determine the maximum loading and has to limit the weight bearing respectively.This is part of the surgeons' education.Stryker offers labeling of best quality (op-tech, ifu) but stryker cannot grant that all users are skilled in the special field of traumatology and have read the labeling with diligence.In the case of an overloading or due to poor implantation technique an implant failure may result.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: WRIST FUSION PLATE STANDARD BEND VARIAX2 120MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7784988
• Report Number: 0008031020-2018-00561
• Device Sequence Number: 1986240
• Product Code: HRS
• UDI-Device Identifier: 07613327131567
• UDI-Public: 07613327131567
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K151178
• 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): 12/06/2018

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: 629579
• Device Lot Number: V30573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 12/06/2018
• 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: 53 YR