MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP RECONSTRUCTION PLATE 8 HOLES/112MM; APPLIANCE,FIXATION,NAIL

Model Number	245.081
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).Date of post-operative infection development is unknown.Implanted in (b)(6) 2017; exact date is unknown.Complainant device is not expected to be returned for manufacturer review/investigation.(b)(4).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 a patient underwent a hardware removal on (b)(6) 2017 due to infection.All hardware was intact and the fracture was healed.The original procedure was an open reduction internal fixation (orif) of the proximal tibia in (b)(6) 2017.There was no surgical delay, no medical intervention was required.The surgery was completed successfully.The patient was stable following surgery.This report is for one (1) 3.5 mm lcp reconstruction plate 8 holes/112 mm.This is report 2 of 6 for complaint pc-(b)(4).

• Brand Name: 3.5MM LCP RECONSTRUCTION PLATE 8 HOLES/112MM
• 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: 7161660
• Report Number: 2939274-2018-50053
• Device Sequence Number: 19320701
• Product Code: KTT
• UDI-Device Identifier: 10886982169624
• UDI-Public: (01)10886982169624(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K000684
• 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): 12/06/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: 245.081
• Device Catalogue Number: 245.081
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 01/03/2018
• 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: 132