MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP® CURVED CONDYLAR PLATE 16 HOLES/350MM-LEFT; APPLIANCE,FIXATION,NAIL

Model Number	02.001.306
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s height reported as (b)(6).Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 or Problem Description
It was reported that an unknown procedure was performed on an unknown date where a patient was implanted with one (1) 4.5 condylar plate, two (2) 4.5 cortex screws, six (6) locking screws and two (2) 1.7 cables.Post-operatively, the patient fell and it was discovered via x-ray on an unknown date that the 4.5 condylar plate broke.Revision surgery was performed on (b)(6) 2017 where all implants were removed and patient was implanted with new hardware.Procedure was completed successfully with no surgical delay and patient status was reported as stable.X-rays are not available.Concomitant devices reported: unknown 4.5 cortex screws (part# unknown, lot# unknown, quantity 2), unknown 5.0 locking screws (part# unknown, lot# unknown, quantity 6), unknown 1.7 cables (part# unknown, lot# unknown, quantity 2).This report addresses the revision surgery due to postoperative broken plate.The intraoperative issue of screw breakage during revision surgery has been captured under related complaint (b)(4).This report is for one (1) 4.5mm lcp curved condylar plate 16 holes/350mm-left.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 4.5MM LCP® CURVED CONDYLAR PLATE 16 HOLES/350MM-LEFT
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7158680
• Report Number: 2939274-2018-50025
• Device Sequence Number: 19136061
• Product Code: KTT
• UDI-Device Identifier: 10886982027597
• UDI-Public: (01)10886982027597(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K041911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.001.306
• Device Catalogue Number: 02.001.306
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 84