MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/4 HOLES/RIGHT; PLATE, FIXATION, BONE

Model Number	02.118.002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Impaired Healing (2378); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown when the plate broke.Additional procode: hwc.Date of implantation is unknown.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 device history records review has been requested.(b)(4).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 the patient underwent an ankle hardware removal on (b)(6) 2018 in order to do an ankle fusion.The variable angle locking compression medial distal tibia (va-lcp med dis tib) plate was being removed and it was noticed that the plate had broken distally.It was non-displaced, so it was not noticed before surgery.The fracture was found to be a non-union.The procedure was successfully completed, with no reported delay.There were no patient consequences reported.Concomitant devices: trauma screws (part: unknown, lot: unknown, quantity: unknown).This report is for a 2.7/3.5 mm va-lcp medial distal tibia plate/4 holes/right.This is report 1 of 1 for (b)(4).
Additional 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.
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.Device history record (dhr): part no.: 02.118.002; lot no.: 9533508; manufacturing location: raron; release to warehouse date: june 30, 2015; no nonconformance reocrds (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No ncrs were generated during production.Patient height was reported as 157 centimeters.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: 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/4 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: 7556795
• Report Number: 2939274-2018-52353
• Device Sequence Number: 210084
• Product Code: HRS
• UDI-Device Identifier: 10886982037589
• UDI-Public: (01)10886982037589
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K120854
• 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,Followup
• Report Date (Section B): 05/09/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.118.002
• Device Catalogue Number: 02.118.002
• Device Lot Number: 9533508
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 06/06/2018; 06/29/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 06/28/2018; 07/05/2018
• 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: 27 YR
• Patient Weight: 104