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

Model Number	02.112.140
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Unknown when pain, infection & discomfort began.Original implant date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4): revision surgery due to pain & discomfort.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional is obtained that was not available for the initial med-watch, the investigation will be updated as applicable, and a follow-up med-watch will be filed as appropriate.
Event or Problem Description
It was reported that a patient had to undergo a hardware removal procedure on (b)(6) 2018 due to pain and discomfort.In addition to the pain and discomfort, the patient reported being able to feel the hardware.The patient was originally implanted with two (2) plates, two (2) 4-hole va medial distal tibia, eight (8) locking screws, six (6) cortex screws, two (2) cannulated screws, two (2) washers and a k-wire on an unknown date.All of the hardware were removed during the april 4 procedure.There was no reported patient consequence.This report involves 8 devices.This report is 1 of 8 for (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.Additional product code: hwc date reported in initial report was 4/5/2018.Correct date should have been 4/4/2018.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
• 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: 7455812
• Report Number: 2939274-2018-51905
• Device Sequence Number: 16521545
• Product Code: HRS
• UDI-Device Identifier: 10886982033932
• UDI-Public: (01)10886982033932
• 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 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): 04/04/2018

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: 02.112.140
• Device Catalogue Number: 02.112.140
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 05/07/2018
• 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: 44 YR
• Patient Weight: 87