MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 10MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE; NAIL, FIXATION, BONE

Model Number	04.004.443S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Nonunion/Delayed-union Bone Fracture (2369); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown when the event occurred.This report is for a nail - unknown lot.Implant date: unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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 on (b)(6) 2017, revision surgery was performed to treat non-union of the right tibia.The original procedure to treat bilateral tibial fractures was performed on an unknown date ten (10) months ago.The surgeon identified that the left tibia presently is in non-union and cellulitis is present as well.Surgeon performed hardware removal which included: one (1) 10 mm x 315 mm ex nail, one (1) 5.0 mm proximal cortical screw and two (2) 4.0 mm distal cortical screws.The surgeon used a reamer irrigator, aspirator (ria) to collect bone graft.The right non-union site was debrided and packed with the graft material, and the site was revised with another manufacturer's devices.There is an external fixation device on the left side, and there is no information regarding future treatment.The hardware was removed without incident and all devices were found to be intact.There were no reported surgical delay.The procedure was completed successfully with the patient in stable condition.This complaint involves four (4) devices.This report is for a nail.This report is 1 of 3 for (b)(4).

• Brand Name: 10MM TI CANNULATED TIBIAL NAIL-EX/315MM-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: 7165534
• Report Number: 2939274-2018-50083
• Device Sequence Number: 1340598
• Product Code: JDS
• UDI-Device Identifier: 10886982084170
• UDI-Public: (01)10886982084170(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: NM
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2017

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: 04.004.443S
• Device Catalogue Number: 04.004.443S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 01/04/2018
• 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: 40 YR
• Patient Weight: 61