MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI LCP® VOLAR DISTAL RADIUS PLATE EXTRA-ARTICULAR/LEFT; PLATE,FIXATION,BONE

Catalog Number 442.461

Device Problem Bent (1059)

Patient Problems Fall (1848); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event was reported as (b)(6) 2017 as that¿s the date when patient fell.It is unknown if the plate bent due to fall or before it.Additional device product code used hwc, ktt.(b)(6).Patient code (b)(4) used to capture additional medical/surgical intervention required.The device was received and the product evaluation is in progress.No conclusion can be drawn.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 (b)(4) reports an event in (b)(6) as follows: it was reported that on (b)(6) 2009, an original surgery was performed with the lcp (locking compression plate) volar distal radius plate.On (b)(6) 2017, the patient fell down behind and landed on her left hand.At that time, the patient had distal radius fracture on her left hand and it was found the implanted plate was bent.On (b)(6) 2017, the re-operation was performed and the bent plate was replaced with the va-tcp plate and the surgery was completed without a delay.There was no adverse consequence to the patient.Concomitant devices reported: ti lcp® volar distal radius plate extra-articular/left (part# 442.461s, lot# 1914547, quantity 1), cortscr ø2.4 self-tap l14 tan (part# 401.764s, lot# 3106557, quantity 1), cortscr ø2.4 self-tap l16 tan (part# 401.766s, lot# 1999296, quantity 1), lockscr ø2.4 self-tap l10 tan (part# 412.810s, lot# 1893806, quantity 1), lockscr ø2.4 self-tap l12 tan (part# 412.812s, lot# 1879048, quantity 1), lockscr ø2.4 self-tap l12 tan (part# 412.812s, lot# 3103336, quantity 1), lockscr ø2.4 self-tap l14 tan (part# 412.814s, lot# 3091966, quantity 2), lockscr ø2.4 self-tap l14 tan (part# 412.814s, lot# 3111759, quantity 1).This report is for one (1) ti lcp volar distal radius plate extra-articular/left.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: dhr review was completed.Non-sterile 442.461 / 5430748 was manufactured in us.Part number: 442.461, lot number: 5430748, part manufacture date: 01-may-2007, supplier: (b)(4), manufactured by synthes (b)(4) - export, nonconformance noted: mrr# 111576, mrr# 111175.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of ti lcp volar distal radius plate extra-articular/left product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.The review of the raw material device history record revealed two material review records (mrr) to be associated to raw material lot 5091448.Mrr# 111576 was generated due to the width of the material exceeding the length on a partial sheet of the material thus preventing the inspector from verifying the grain/roll direction of the material.The quality engineer verified the grain/roll direction of the partial sheet of raw material and the material was dispositioned to be used as is.Since the grain/roll direction of the material could be verified, mrr# 111576 is not relevant to this complaint as the correct grain/roll direction would not result in a bent plate.Mrr# 111175 was generated due to out of specification surface roughness on a portion of the raw material lot 5091448.The material was dispositioned as ¿use as is¿ as the surface of the material will be cleaned up during normal processing.Since the material was determined to be usable as is, mrr# 111175 is not relevant to this complaint as the surface finish of the plate would not result in a bent plate.This raw material lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.The returned plate was confirmed to be bent.Some surface wear and scratches were observed on the plate which are consistent with implantation and removal.Replication is not applicable to the complaint condition as the device is already bent.The drawings were reviewed during investigation.The plate thickness was measured to be 2.01mm which is within the specification of 2.0 +0.13/-0.10.Based on review of the dhr records there is no indication that any material issues contributed to the complaint condition.A dcrm review and complaint history review were conducted.Product family: lcp volar distal radius plate - 442.458 ¿ 442.468(s) complaint condition: plate bent postoperatively legacy - 2.4mm lcp distal radius plates dcrm was reviewed.The complaint is adequately addressed by the risk assessment.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: TI LCP® VOLAR DISTAL RADIUS PLATE EXTRA-ARTICULAR/LEFT
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7126511
• MDR Text Key: 95177936
• Report Number: 8030965-2017-50794
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819830233
• UDI-Public: (01)07611819830233(10)5430748
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 442.461
• Device Lot Number: 5430748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 58