MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP PROXIMAL TIBIA PLATE 10 HOLES/190MM-RIGHT; PLATE, FIXATION, BONE

Model Number	240.042
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient height reported as 5¿3¿ date of event: date patient pain began is not known.Complainant part 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.Dhr review was completed.Part number: 240.042.Lot number: h281539.Part mfg date: 24-jan-2017.Part exp.Date: n/a.Manufacturing location: (b)(6).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 proximal tibia plates was processed through the normal manufacturing and inspection operations with no non-conformance noted.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.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.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 patient underwent an open reduction internal fixation (orif) of the elbow and tibia on (b)(6) 2017.On unknown date patient reported experiencing pain at the implant site.Patient was returned to surgery on (b)(6) 2018 where surgeon removed all hardware.Hardware removed included one (1) 2.7mm/3.5mm variable angle locking compression plate (va lcp) olecranon plate, six (6) locking screws, two (2) cortex screws, one (1) 4.5mm lcp proximal tibia plate, seven (7) locking screws, and two (2) cortex screws.This report is for one (1) lcp proximal tibia plate.This is report 2 of 3 for (b)(4).

• Brand Name: 4.5MM LCP PROXIMAL TIBIA PLATE 10 HOLES/190MM-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: 7387086
• Report Number: 2939274-2018-51370
• Device Sequence Number: 16395752
• Product Code: HRS
• UDI-Device Identifier: 10886982164551
• UDI-Public: (01)10886982164551(10)H281539
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K052390
• 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): 03/05/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 240.042
• Device Catalogue Number: 240.042
• Device Lot Number: H281539
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 03/30/2018
• 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: 52