MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/3H SHAFT/LT; PLATE,FIXATION,BONE

Catalog Number 04.111.531

Device Problem Bent (1059)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.Date of event is unknown.Additional device product code: hwc.Device was implanted in (b)(6) 2017; exact date is unknown.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.A review of the device history records has been requested and is currently pending completion.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 europe reports an event in (b)(6) as follows: it was reported that initially a patient underwent an open reduction internal fixation (orif) for left extra articular fracture in (b)(6) 2017 and was implanted with variable angle-locking compression (va-lcp) two column distal radius plate.Patient was readmitted post fall.The plate had bent and the wrist had fractured at the same place as original fracture.Patient underwent a revision surgery on (b)(6) 2018.Concomitant devices reported unknown locking screw (part # unknown, lot # unknown, quantity unknown).This is report 1 of 1 for complaint (b)(4).

Event Description

Further it was clarified that initial implant surgery was performed in (b)(6) 2017 and not in july 2017 as previously reported.

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.Implant date: device was implanted in (b)(6) 2017; exact date is unknown.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.

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.Additional narrative: patient ethnicity is unknown.Event: surgical outcome added.Device evaluated by mfr, device manufacture date: part: 04.111.531; lot: 9695532; manufacturing site: mezzovico; release to warehouse date: october 21, 2015; the device history record shows this lot of 24 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.The manufacturing documents were reviewed and no complaint related issues were found.The review of the raw material certificate 18606 has shown that the used material was ti-cp grade 4 according to implants for surgery norm iso 5821-2.Investigation site: (b)(4); selected flow: 3.Damaged: visual | examples: deformed; visual inspection: the plate is deformed in the area of the k-wire holes and the locking thread of the first combi-hole next to the k-wire holes.As expected at a used plate are wear marks at the thread flanks of the locking threads visible.Otherwise the plate is in a good condition.Dimensional inspection: checked dimensions with caliper 3-01-19789: plate thickness at deformation; specification 2mm +/-0.09 / measured: 1.97mm = pass drawing/specification review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused damage at the device, therefore no drawing/specification review is needed.Summary: the complaint is confirmed, as the plate is deformed as complained.This lot of 24 pieces was manufactured in october 2015 and we are not aware of any other complaint for this article and lot number combination.Based on that, and the investigation findings, a manufacturing related issue can be excluded.Based on the complaint description, it can be assumed that a mechanical overload during the described fall did lead to the deformation of the plate.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 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

Revision surgery was completed successfully, with no delay.

• Brand Name: 2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/3H SHAFT/LT
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7540889
• MDR Text Key: 109145772
• Report Number: 8030965-2018-53960
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819391413
• UDI-Public: (01)07611819391413
• Combination Product (y/n): N
• PMA/PMN Number: K092556
• 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: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.111.531
• Device Lot Number: 9695532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Date Manufacturer Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention