MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.004.549S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s id and weight were not provided for reporting.Date of event is unknown.Implant date: unknown.Explant date: unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 was originally implanted with an unknown large fragment plate, unknown locking screws, unknown non-locking screws and the cannulated tibial nail on an unknown date.Recently,on an unknown date, the patient fell and broke his tibia loose while riding an inner tube.A total knee replacement was planned for this patient.Patient underwent a removal of the cannulated tibial nail on an unknown date due to a non-union fracture and broken cannulated tibial nail.The cannulated tibial nail ultimately was broken before the surgery started.Only the proximal broken fragment was successfully retrieved from the patient.The surgeon attempted to extract the nail but eventually changed the plan to a basic total knee replacement.The plate, locking screws and non-locking screws were not removed and they remained intact.The procedure was successfully completed.There was a 45-minute surgical delay and the patient outcome was good.Concomitant devices reported: large fragment plate (part number: unknown, lot number: unknown, quantity:1), non-locking screws (part number: unknown, lot number: unknown, quantity:4), locking screws (part number: unknown, lot number: unknown, quantity:1) this report is for one (1) 11 mm ti cannulated tibial nail-ex/345 mm-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 11MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7818725
• Report Number: 2939274-2018-53482
• Device Sequence Number: 2347825
• Product Code: JDS
• UDI-Device Identifier: 10886982084491
• UDI-Public: (01)10886982084491
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• 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): 08/08/2018

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: 04.004.549S
• Device Catalogue Number: 04.004.549S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/27/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR