MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP® CONDYLAR PLATE 10 HOLES/242MM-RIGHT; PLATE, FIXATION, BONE

Model Number	222.660
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product codes: hty, jdw, hwc.Date of implant reported as (b)(6) 2017, exact date is not known.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is synthes sales consultant the investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 a patient was implanted with a synthes locking compression plate (lcp) distal femur plate and 10 unknown screws on an unknown date in (b)(6) 2017 to treat a distal femur fracture.Postoperatively, on an unknown date in (b)(6) 2018, the patient presented with leg pain and was referred to the emergency room.On an unknown date, while in the er, it was identified that the plate had broken at one of the screw holes.On (b)(6) 2018, the patient was returned to the operating room where the surgeon successfully removed the 10 screws and the broken plate and the patient was revised to a 12-hole 4.5mm lcp broad plate, an unknown quantity of unknown screws, and a non-synthes fibular strut and cables to stabilize the non-union.There were no intraoperative malfunctions and the procedure was completed successfully.Concomitant devices reported: screws (part number unknown, lot number unknown, quantity 10).This report is for one (1) 4.5mm lcp condylar plate 10 hole 242mm right this is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A device history record review was performed for the subject device: part number: 222.660 lot number: 5111542 part mfg date: 08-dec-2005 part exp.Date: n/a manufacturing location: elmira, new york nonconformance¿s noted: material review record (mrr).Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 4.5mm lcp condylar 10 holes plates was processed through the normal manufacturing and inspection operations with one non-conformance noted.Mrr was intiated due to two parts having incomplete threads.The two non-conforming parts were scrapped per mrr.Therefore, mrr is not relevant to this complaint.This 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.The review of the raw material device history record revealed this lot met all specifications with no non-conformance 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.Mrr is not relevant to this complaint condition as the non-conforming parts were scrapped.This lot met all dimensional and visual criteria at the time of manufacture.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 LCP® CONDYLAR PLATE 10 HOLES/242MM-RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7371545
• Report Number: 2939274-2018-51220
• Device Sequence Number: 84505
• Product Code: HRS
• UDI-Device Identifier: 10886982157362
• UDI-Public: (01)10886982157362(10)5111542
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K000066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2018

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: 222.660
• Device Catalogue Number: 222.660
• Device Lot Number: 5111542
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 04/25/2018
• 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 Age: 67 YR