MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/6 HOLES/RIGHT; PLATE, FIXATION, BONE

Model Number	02.118.004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	10/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on (b)(6) 2019, the patient had a nonunion on the distal tibia with a medial distal tibia plate.A total of five distal screws were broken, four (4) unknown 2.7 mm va locking screws and one (1) 3.5 mm cortical screw.Two screw fragments were left in the bone.Patient was treated for the nonunion today with antibiotic beads and will comeback for a follow up surgery at a later date.It was unknown if there was surgical delay.Procedure and patient outcome was unknown.This complaint involves six (6) devices.This is 1 of 6 for report (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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 information provided for reporting.A review of the device history record.Part: 02.118.004-us, lot: 1l95419, manufacturing site: raron, release to warehouse date: 19.Oct.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Review of the device history record.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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
Update: this report is for one (1) 2.7/3.5mm va-lcp medial distal tibia plate/6 holes/right.

• Brand Name: 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/6 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: 9240797
• Report Number: 2939274-2019-61710
• Device Sequence Number: 1934705
• Product Code: HRS
• UDI-Device Identifier: 10886982037626
• UDI-Public: (01)10886982037626
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2019

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: 02.118.004
• Device Catalogue Number: 02.118.004
• Device Lot Number: 1L95419
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 11/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention