MAUDE Adverse Event Report: STRYKER GMBH STRAIGHT PLATE VARIAX FIBULA FIBULA, 7 HOLE / L96MM; PLATE, FIXATION, BONE

Model Number	40-20807S
Medical Device Problem Codes	Break (1069); Fracture (1260); Off-Label Use (1494)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "i have just supported a case in which a broken variax 2 straight fibula plate (ref: 40-20807s lot: l22271) was removed from a patients ulnar (the implant was used to treat a 22a2 ao classification fracture, when it is licensed to treat a variation of 44 ao classified fractures.).The broken plate has been replaced by a variax 2 broad compression plate (629548s).This revision surgery took lasted 1.5 hours.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note the correction to d9/h3 as the device was not returned for evaluation.The reported event could be confirmed, from the x-rays provided for evaluation and matches the alleged failure mode.The device inspection revealed the following: a device inspection was not possible since the affected device was not returned but x-rays were provided which confirms the post operative breakage and off label use as the device was meant to be used for fibula but was used in ulnar.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to a user related issue.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device disposition unknown.
Event or Problem Description
As reported: "i have just supported a case in which a broken variax 2 straight fibula plate (ref: 40-20807s lot: l22271) was removed from a patients ulnar (the implant was used to treat a 22a2 ao classification fracture, when it is licensed to treat a variation of 44 ao classified fractures.).The broken plate has been replaced by a variax 2 broad compression plate (629548s).This revision surgery took lasted 1.5 hours.".

• Brand Name: STRAIGHT PLATE VARIAX FIBULA FIBULA, 7 HOLE / L96MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17298002
• Report Number: 0008031020-2023-00274
• Device Sequence Number: 14421806
• Product Code: HRS
• UDI-Device Identifier: 04546540667809
• UDI-Public: 04546540667809
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K102282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2023

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 Model Number: 40-20807S
• Device Catalogue Number: 4020807S
• Device Lot Number: L22271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown