MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM LCP(TM) CONDYLAR PLATE 7 HOLES SHAFT; PLATE, FIXATION, BONE

Model Number	249.684
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.The investigation could not be completed; no conclusion could be drawn.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.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) 2019, the patient underwent a removal of hardware to broken (1) locking compression plate (lcp) condylar plate, thirteen (13) locking screws (7 locking screws broke), one (1) variable angle (va)-locking compression plate (lcp) lateral distal fibula plate, one (1) variable angle (va)-locking compression plate (lcp) anterolateral distal tibia plate and 8 cortex screws due to nonunion and delayed healing.All hardware removed except for a short segment of a 2.7 va locking screw shaft.The patient required fusion of ankle and underwent an insertion hindfoot nail.Patient originally had an open reduction and internal fixation (orif) of distal tibia fracture on (b)(6) 2018.Fragments were generated and were easily removed without additional intervention.There was no surgical delay.The procedure was completed successfully.Patient status was stable.Concomitant devices reported: variable angle (va)-locking compression plate (lcp) lateral distal fibula plate (part # 02.118.406, lot # unknown, quantity 1); variable angle (va)-locking compression plate (lcp) anterolateral distal tibia plate (part # 02.118.202, lot # unknown, quantity 1); unknown locking screws (part # unknown, lot # unknown, quantity 6); 2.7 cortex screws (part # unknown, lot # unknown, quantity 4); 3.5 cortex screws (part # unknown, lot # unknown, quantity 4).This complaint involves two (2) devices.This report is for one (1) 2.7mm lcp(tm) condylar plate 7 holes shaft.This report is 1 of 2 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.Date of implantation is an unknown date in (b)(6) 2018.Date of concomitant therapy is the same as date of implantation, an unknown date in (b)(6) 2018.Without a lot number the device history records review could not be completed.Product was not returned.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.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 LCP(TM) CONDYLAR PLATE 7 HOLES SHAFT
• 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: 8466884
• Report Number: 2939274-2019-57185
• Device Sequence Number: 1436293
• Product Code: HRS
• UDI-Device Identifier: 10886982171290
• UDI-Public: (01)10886982171290
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K063049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 249.684
• Device Catalogue Number: 249.684
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 04/30/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Weight: 70