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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.No patient information is available for reporting.Date of event: it is unknown when non-union occurred.Implanted date: original implant date unknown.Device is not available for return.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.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 was implanted with a synthes 11mm titanium (ti) cannulated tibial nail and five (5) locking screws to treat an unknown tibia fracture on an unknown date.Postoperatively, on an unknown date, it was identified that there was a non-union of the fracture and on (b)(6) 2017, the patient was returned to the operating room where the nail and screws were removed and the patient was revised using a new tibial nail.The procedure was completed successfully.No surgical delay was noted.Patient status is unknown this is report 1 of 6 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: 7161309
• Report Number: 2939274-2018-50051
• Device Sequence Number: 16632256
• Product Code: JDS
• UDI-Device Identifier: 10886982084491
• UDI-Public: (01)10886982084491(17)EXPIRATIONUNKNOWN(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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): 12/07/2017

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: 04.004.549S
• Device Catalogue Number: 04.004.549S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 01/03/2018
• 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