MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP® CURVED CONDYLAR PLATE 12 HOLES/278MM-LEFT; APPLIANCE, FIXATION, NAIL

Model Number	02.001.302
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient gender and weight are unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Part 02.001.302, lot 6996914: manufacture date: august 06, 2012.Manufacturing location: (b)(4).A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 4.5mm condylar plates was processed through the normal manufacturing and inspection operations.This lot met all dimensional and visual criteria at the time of product 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 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.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 on (b)(6) 2018, the patient underwent a hardware removal of a plate and screws due to post-operative plate breakage.The 4.5mm locking compression plate (lcp) curved condylar plate, 12 holes and ten (10) screws; 4.0mm locking and 5.0mm cannulated locking screws were easily removed intact.No surgical delay.Procedure completed successfully.The patient was initially implanted with the hardware on an unknown date.Concomitant devices reported: 4.0mm locking screw (part unknown, lot unknown, quantity unknown), 5.0mm cannulated locking screw (part unknown, lot unknown, quantity unknown).This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM LCP® CURVED CONDYLAR PLATE 12 HOLES/278MM-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: 7496473
• Report Number: 2939274-2018-52096
• Device Sequence Number: 11091277
• Product Code: KTT
• UDI-Device Identifier: 10886982027559
• UDI-Public: (01)10886982027559
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K041911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2018

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: 02.001.302
• Device Catalogue Number: 02.001.302
• Device Lot Number: 6996914
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/08/2018
• 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: 75 YR