MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH V 2.4MM TI VA-LCP VOLAR RIM DSTL RADIUS PLATE/6H HD/5H SHAFT/LT; PLATE,FIXATION,BONE

Catalog Number 04.115.751

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Rash (2033); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Additional product code: hwc.A review of the device history record has been requested.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device is not distributed in the united states but is similar to device marketed in the usa.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient has developed skin rash around the implant zone after two years of implantation.The skin biopsy was suggestive of vasculitis lined to metal reaction- orif of wrist (distal radius)lt.The patient is scheduled for revision surgery for hardware removal.There would be 1 plate and 6 screws are involved.Patient condition was unknown.This is report 1 of 7 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.We received back the part in a used condition.Dcrm verifies that the used material is biocompatible.In conclusion, the complaint does not implicate a design related issue nor does it create any additional risk to the patient.No further actions required from a product development perspective.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part: 04.115.751, lot: l278384, manufacturing site: mezzovico, release to warehouse date: 27.Jan.2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: V 2.4MM TI VA-LCP VOLAR RIM DSTL RADIUS PLATE/6H HD/5H SHAFT/LT
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9538310
• MDR Text Key: 188706533
• Report Number: 8030965-2020-00001
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819423060
• UDI-Public: (01)07611819423060
• Combination Product (y/n): N
• PMA/PMN Number: K110125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.115.751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Date Manufacturer Received: 01/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR