MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/8 HOLES/LEFT; PLATE, FIXATION, BONE

Model Number	02.118.207
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).Additional product code: hwc.Date of implant reported as (b)(6) 2018, exact date is not known.Dhr review was completed.Part# 02.118.207, lot# h477525, mfg date: 24 october 2017, mfg location: (b)(6), expiration date: 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 2.7/3.5mm va-lcp anterolateral distal tibia 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.A dhr review for raw material p/n 14089 is not required as the product was not broken 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.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 ankle procedure in (b)(6) 2018 to implant two (2) locking compression plate (lcp) one third tubular plates, one (1) 2.7/3.5mm variable angle locking compression plate (va-lcp) anterolateral distal tibia plate, one (1) 2.7/3.5mm variable angle locking compression plate (va-lcp) medial distal tibia plate, thirteen (13) 3.5mm cortex screws, twelve (12) 2.7mm va locking screws, one (1) 7.0mm washer, one (1) 4.0mm cannulated screw, and one (1) 4.0mm cancellous screw.Patient was returned to surgery on september 17, 2018 where all hardware was removed due to infection, inflammation, and delayed healing.Surgery was completed successfully with no delay.Patient status reported as okay.Patient is reported to be incarcerated and non-compliant.This report is for one (1) 2.7/3.5mm va lcp anterolateral distal tibia plate.This is report 3 of 9 for (b)(4).

• Brand Name: 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/8 HOLES/LEFT
• 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: 7944321
• Report Number: 2939274-2018-54226
• Device Sequence Number: 19397016
• Product Code: HRS
• UDI-Device Identifier: 10886982038401
• UDI-Public: (01)10886982038401
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K121601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2018

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: 02.118.207
• Device Catalogue Number: 02.118.207
• Device Lot Number: H477525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/08/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Weight: 72