MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/12H/LEFT/213MM; PLATE,FIXATION,BONE

Model Number	02.112.527
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tissue Damage (2104)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 an unknown date, the patient came to surgery for removal of exposed hardware, a takedown of nonunion, and application of max frame ring fixator.The patient underwent an open reduction internal fixation (orif) several months back.The fracture has gone on to nonunion and the soft tissue over the plate distally has opened with the hardware exposed to the air.All hardware was intact and removed easily.The nonunion was debrided and bone grafted.The open area distally was debrided and irrigated.All incisions were closed, and a maxframe ring fixator was applied to stabilize the fracture.The original date of implantation was unknown.The procedure and patient outcomes were unknown.This complaint involves seventeen (17) devices.(b)(4).

• Brand Name: 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/12H/LEFT/213MM
• 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: 9983481
• Report Number: 2939274-2020-01961
• Device Sequence Number: 17232179
• Product Code: HRS
• UDI-Device Identifier: 10886982034656
• UDI-Public: (01)10886982034656
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K013248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2020

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: 02.112.527
• Device Catalogue Number: 02.112.527
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 04/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR