MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM LCP POSTLAT DISTAL FIBULA PLATE 4H/RIGHT/90MM; PLATE,FIXATION,BONE

Model Number	02.112.108
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
Date of postoperative infection development is unknown.Additional device product code: hwc.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.A review of the device history records has been requested and is currently pending completion.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) 2018 the patient underwent removal of the locking compression plate (lcp) posterolateral distal fibula plate and six screws on the right ankle due to infection.Removal took place 5 months after implantation on (b)(6) 2018, one (1) lcp postlat distal fibula plate, two (2) unknown 3.5 cortex screws, three (3) unknown 2.7 locking screws and one (1) 2.7 cortex screw were removed.There was no surgical delay reported.Patient surgery was successfully completed.This report is for (1) 2.7mm/3.5mm lcp postlat distal fibula plate 4h/right/90mm.This is report 1 of 4 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.A device history record (dhr) review was conducted for part #: 02.112.108, lot #: 6205605 (non-sterile) ¿ 2.7mm/3.5mm lcp postlat distal fibula plate 4h/right/90mm.25-jul -2018: dhr reviewed by: mschoenfeld, manufacturing location: monument, manufacturing date: 28-aug-2009, lot quantity: 12: work order traveler for this lot met all inspection acceptance criteria.In-process acceptance sheet, met all inspection acceptance criteria.Process test disposition forms dated 28-aug-2009 indicated acceptance.In-process acceptance sheet, met all inspection acceptance criteria.Inspection sheet, met all inspection acceptance criteria.Inspection sheet for final inspection met all inspection acceptance criteria.Packaging label log, lppf, lmd/lpf rev b was reviewed and found to be conforming.Packaging bom was reviewed and found to be conforming.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues identified during the manufacture of the product 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.

• Brand Name: 2.7MM/3.5MM LCP POSTLAT DISTAL FIBULA PLATE 4H/RIGHT/90MM
• 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: 7698955
• Report Number: 2939274-2018-52964
• Device Sequence Number: 11022942
• Product Code: HRS
• UDI-Device Identifier: 10886982033376
• UDI-Public: (01)10886982033376
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083213
• 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,Followup
• Report Date (Section B): 06/27/2018

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: 02.112.108
• Device Catalogue Number: 02.112.108
• Device Lot Number: 6205605
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 08/03/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 66