MAUDE Adverse Event Report: STRYKER GMBH VOLAR DR PLATE INTERM. LEFT LONG; PLATE, FIXATION, BONE

Model Number	54-25677S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	03/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The surgeon reported that the patient was reviewed in follow up clinic and withe variax distal radius plate had bent.The patient will require revision, but no date has been set yet.Additionally reported: mobilisation instructions: 2 weeks in a back slap cast, return to fracture clinic at 2 weeks for futuro split to be removed for gentle mobilisation patient cooperation: patient says followed plan, only used hand to play playstation with son.
Event or Problem Description
The surgeon reported that the patient was reviewed in follow up clinic and withe variax distal radius plate had bent.The patient will require revision, but no date has been set yet.Additionally reported: mobilisation instructions: 2 weeks in a back slap cast, return to fracture clinic at 2 weeks for futuro split to be removed for gentle mobilisation patient cooperation: patient says followed plan, only used hand to play playstation with son.
Additional Manufacturer Narrative
Correction: refer to d10/h3, h6-patient code.The reported event that volar dr plate interm.Left long was alleged of "implant - deformation post-operative" could be confirmed based on the x-rays sent.The x-rays received were sent to our medical expert in order to evaluate the case.Here is the medical statement: "based on the information given, we might not entirely find the root cause for the bending of this plate during the routine follow-up.The fracture was adequately reduced and post-operative instructions were followed according to the surgeons instructions and the patient¿s record.There is no doubt that a force is needed to bend the plate.A possibility might be that the casts were molded in a way giving pressure/ force on the plate and the fracture.This is a potential explanation of the bending." therefore, the root-cause for this event cannot be determined.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 complaint report will be updated.H3 other text : device disposition is unknown.

• Brand Name: VOLAR DR PLATE INTERM. LEFT LONG
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9946459
• Report Number: 0008031020-2020-01163
• Device Sequence Number: 3303837
• Product Code: HRS
• UDI-Device Identifier: 04546540729521
• UDI-Public: 04546540729521
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K133974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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: 54-25677S
• Device Catalogue Number: 54-25677S
• Device Lot Number: 1000330221
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 07/08/2020
• 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: 35 YR
• Patient Weight: 77