MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM RECONSTRUCTION PLATE 10 HOLES/118MM; APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT

Model Number 245.00

Device Problem Bent (1059)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Patient¿s weight is unknown.Additional device product code: kwp.Complainant device is not expected to be returned for manufacturer.Review/investigation.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

It was reported that a revision procedure was performed for ors right clavicle because the patient had a bicycle accident and re-injured himself on the same site.There was non-union and the plate was bent.The original plate was removed and a new plate was inserted.There was no surgical delay.Patient outcome was stable.Surgery was completed successfully.This report is for one (1) 3.5mm reconstruction plate 10 holes/118mm.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

A device history record review was performed for the subject device: part number: 245.00 lot number: 4923725 part manufacture date: 28-jan-2005 manufacturing location: (b)(4) part expiration date: n/a.Nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 3.5mm reconstruction plate 10 holes/118mm 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.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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.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: 3.5MM RECONSTRUCTION PLATE 10 HOLES/118MM
• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• 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: 7086447
• MDR Text Key: 93837598
• Report Number: 2939274-2017-50155
• Device Sequence Number: 1
• Product Code: KTW
• UDI-Device Identifier: 10886982169334
• UDI-Public: (01)10886982169334(10)4923725
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 245.00
• Device Catalogue Number: 245.00
• Device Lot Number: 4923725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2018
• Date Device Manufactured: 01/28/2005
• 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