MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM LCP(TM) L-PLATE OBLIQUE LEFT 2H HEAD/3H SHAFT; PLATE,FIXATION,BONE

Model Number	249.687
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 narrative: date of event is unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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) 2017 patient had an external fixation for a talus fracture.Patient was brought back for a planned open reduction internal fixation (orif) on (b)(6) 2017, were a 2.7mm locking compression plate (lcp), three cannulated screws, and six cortex screws were implanted.On (b)(6) 2017, the patient had a hardware removal due to infection, no malfunction of product reported.A plate and screws were removed.Surgery was successfully completed with no delay.The patient outcome was reported as okay.This report is for one (1) 2.7mm lcp¿ l-plate oblique left 2h head/3h shaft.(b)(4).

• Brand Name: 2.7MM LCP(TM) L-PLATE OBLIQUE LEFT 2H HEAD/3H SHAFT
• 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: 7148133
• Report Number: 2939274-2017-50448
• Device Sequence Number: 13730505
• Product Code: HRS
• UDI-Device Identifier: 10886982171320
• UDI-Public: (01)10886982171320(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K063049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 11/29/2017

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: 249.687
• Device Catalogue Number: 249.687
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/27/2017
• 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: 26 YR
• Patient Weight: 72