MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP® MEDIAL DISTAL TIBIA PLATE W/O TAB 8 HOLES-RIGHT; PLATE, FIXATION, BONE

Model Number	238.704
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).Date of event: date of infection is not known.Date of implant reported as 2006, exact date is not known.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.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 patient underwent an open reduction internal fixation (orif) of the ankle on unknown date in 2006.Patient was implanted with a 3.5mm locking compression plate (lcp) metaphyseal plate, 3.5mm lcp medial distal tibia plate, 3.5mm lcp anterolateral distal tibia plate, fifteen (15) 3.5mm locking screws, and five (5) 3.5mm cortex screws.On unknown date patient developed an infection of the ankle.X-ray taken on unknown date revealed one of the screws was also broken.It is unknown if the broken screw was a locking or cortex screw.Patient was returned to surgery on (b)(6) 2018 where surgeon removed the three (3) plates and nineteen (19) screws easily.The broken screw was trephined in order to accommodate removal.Surgery was completed successfully with no delay.Patient status reported as okay.This report is for one (1) 3.5mm lcp medial distal tibia plate.This is report 5 of 6 for (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was conducted: part mfg date: 03-feb-2006, part exp.Date: n/a, manufacturing location: depuy synthes ¿ (b)(4), lot number: 4964152 split to 5168219, part number: 238.704: dhr record review: a review of the device history record (dhr) revealed no non-conformances.The dhr shows lot# 5168219 of 3.5mm lcp medial distal tibia plate was processed through the normal manufacturing and inspection operations with no non-conformances or rework 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.A review of the raw material dhr revealed this lot met all specifications with no non-conformances or rework noted.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

• Brand Name: 3.5MM LCP® MEDIAL DISTAL TIBIA PLATE W/O TAB 8 HOLES-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: 7538938
• Report Number: 2939274-2018-52292
• Device Sequence Number: 11206313
• Product Code: HRS
• UDI-Device Identifier: 10886982162113
• UDI-Public: (01)10886982162113
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K013248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

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: 238.704
• Device Catalogue Number: 238.704
• Device Lot Number: 4964152
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 06/18/2018
• 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: 57 YR
• Patient Weight: 84