MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP® MEDIAL PROXIMAL TIBIA PLATE 4H/LEFT 93MM; PLATE,FIXATION,BONE

Model Number	239.955
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient id: (b)(4).Date of event is unknown.Device is not expected to be returned for manufacturer review/investigation.Device history records review was completed for part# 239.955, lot# h415454.Manufacturing location: (b)(4), manufacturing date: jul 28, 2017.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 3.5mm lcp medial proximal tibia 4h/left 93mm 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.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 patient underwent initial surgery on (b)(6) 2017.The patient returned to clinic with failure of open reduction of internal fixation(orif) medial proximal tibia, due to infection, inflammation, and nonunion.Patient underwent hardware removal surgery on (b)(6) 2018.The surgeon evacuated joint fluid and removed one (1) 3.5mm lcp medial proximal tibia plate 4h/left 93mm, three (3) 3.5mm cortex screws, and four (4) 3.5mm locking screws.All hardware was intact.Surgeon stated he had done a lateral ligament repair on patient and the wound had dehisced on that side.His repair had fallen apart and the patient started going into varix which most likely caused the orif on the medial side to fail.The procedure was completed successfully and the patient status was reported as ok/complete.This report is for one (1) 3.5mm lcp® medial proximal tibia plate 4h/left 93mm.This is report 1 of 3 for (b)(4).

• Brand Name: 3.5MM LCP® MEDIAL PROXIMAL TIBIA PLATE 4H/LEFT 93MM
• 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: 7428473
• Report Number: 2939274-2018-51652
• Device Sequence Number: 13943813
• Product Code: HRS
• UDI-Device Identifier: 10886982163493
• UDI-Public: (01)10886982163493(10)H415454
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K050646
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2018

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: 239.955
• Device Catalogue Number: 239.955
• Device Lot Number: H415454
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 04/13/2018
• 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: 53 YR
• Patient Weight: 142