MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/4H/LEFT/109MM; PLATE, FIXATION, BONE

Model Number	02.112.511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s weight is unknown.Date of event is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.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 a patient underwent removal of one (1) synthes 4-hole 3.5 mm locking compression plate (lcp) low bend medial distal tibia plate and seven (7) unknown screws on (b)(6) 2018 due to an open wound over medial ankle and an exposed medial plate.The patient already had an orthofix ring fixator on the left tibia when they underwent an open reduction internal fixation of the left distal tibia to be implanted with the medial plate and seven unknown screws construct on (b)(6) 2017.Subsequently, the patient returned to the operating room for removal of the medial plate and all screws due to the open wound and the exposed plate.The surgeon planned to remove the external fixator and the medial plate.The surgeon made an incision and drained all wounds before removing all hardware successfully.All hardware was removed intact.The wound care and the removal procedure was completed successfully, multiple x-rays (unavailable) were taken during the procedure.There were no patient consequences and the patient was reported to be stable.Concomitant devices reported: orthofix ring fixator (part# unknown, lot# unknown, quantity# 1).This report is for one (1) 3.5mm lcp low bend medial distal tibia plate/4h/left/109mm.This is report 1 of 2 for complaint (b)(4).

• Brand Name: 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/4H/LEFT/109MM
• 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: 7271166
• Report Number: 2939274-2018-50636
• Device Sequence Number: 1028747
• Product Code: HRS
• UDI-Device Identifier: 10886982034496
• UDI-Public: (01)10886982034496(10)LOTNUMBERUNKNOWN
• 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
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2018

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: 02.112.511
• Device Catalogue Number: 02.112.511
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 02/14/2018
• 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: 66 YR