MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE 5H/RIGHT/99MM; PLATE, FIXATION, BONE

Catalog Number 02.112.140

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Date infection began is not known.Additional product code: hwc.Date of implant 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# 02.112.140.Lot# h050624, date of mfg: 09 march 2016.Place of mfg: (b)(4) synthes usa.Part expiration: n/a.Noted nonconformances: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 2.7mm/3.5mm lcp lateral distal fibula plate product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release 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 Description

It was reported patient was implanted with a 2.7mm/3.5mm locking compression plate (lcp) lateral distal fibula plate, three (3) 3.5mm cortex screws, one (1) 3.5mm locking screw, and five (5) 2.7mm locking screws on unknown date for repair of a fibular fracture.On unknown date it was determined patient had developed an infection at the implant site.Patient was returned to surgery on (b)(6) 2018 for removal of all hardware.All devices were removed without issue, no hardware failure was reported.Surgery was completed successfully with no patient consequences.No additional hardware was required, no additional surgery is planned.This report is for one (1) 2.7/3.5mm lcp lateral distal fibula plate this is report 1 of 4 for (b)(4).

Manufacturer Narrative

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: 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE 5H/RIGHT/99MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7593329
• MDR Text Key: 110811938
• Report Number: 2939274-2018-52473
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K083213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.112.140
• Device Lot Number: H050624
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Weight: 150