MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM VA-LCP CURVED CONDYLAR PLATE/14HOLE/301MM/RT-STER; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.414S

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.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 that on an unknown date, a fracture and non-union occurred after the plate snapped.The initial surgery from a mid-shaft femoral fracture had been performed on (b)(6) 2018.The fracture did not heal / non-union, and after 15 months, the plate eventually snapped (x-ray included).Revision surgery was performed on (b)(6) 2019 and has been replaced with a 16-hole va-lcp condylar plate.The patient was discharged to recover at home while being closely observed by surgeon.This report is for one (1) 4.5 mm va-lcp curved condylar plate / 14hole / 301 mm / rt-ster.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthese 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 synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.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

No fragments were generated from the broken device and all components were removed without difficulty.No other medical interventions were required.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity unknown).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: investigation summary: the device was forwarded to manufacturing site for investigation with thee following results: returned item has been received not in original packaging.Information etched on plate match to complaint system and dhr.The returned plate is broken post-production at level of the hole va-8.The returned item has been manufactured and then released in january 2018 according drawing se_366691 rev.H valid from feb 19, 2016.The involved lot has been manufactured starting from the blank art.60067383/ lot l497420 produced with the raw material art 60010028/ lot pf39963 (stainless steel 1.4441 as per se_366691 rev h) no non-conformances or document change have been identified which may be related to the complaint condition.The returned part was reinspected for all the features relevant to the complaint condition.The measurable features (thickness, width and holes features) have been found conforming to manufacturing specifications.The complaint condition is confirmed due to evidence that the item is broken as reported in the complaint, but it is considered not manufacturing related because no manufacturing defect or deficiency have been identified.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot part: 02.124.414s; lot: l701256; manufacturing site: mezzovico; release to warehouse date: (b)(6) 2018; expiry date: january 01, 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance 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: 4.5MM VA-LCP CURVED CONDYLAR PLATE/14HOLE/301MM/RT-STER
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9167813
• MDR Text Key: 161814866
• Report Number: 8030965-2019-69161
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819455924
• UDI-Public: (01)07611819455924
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.414S
• Device Lot Number: L701256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Date Manufacturer Received: 11/22/2019
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA.
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR