MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 10MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE; NAIL, FIXATION, BONE

Model Number	04.004.452S
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier, date of birth, and weight not available for reporting.Device remains implanted; as such explant date is not applicable.Complainant part is not expected to be returned for manufacturer review/investigation, it remains implanted.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 the connecting bolt was very difficult to disconnect from the tibial nail during a tibial nail procedure with suprapatellar approach on (b)(6) 2017.The connecting bolt was stuck on the nail (almost like it was cold welded to nail).The surgeon struggling with the bolt for at least five minutes; however, it would not move.The surgeon finally used a cannulated shaft with an 8mm hex along with a ratchet wrench to disconnect the bolt.The nail remained implanted.The surgery was successfully completed with at least a five (5) minute delay.The patient outcome was as expected.Concomitant devices reported: cannulated shaft with 8mm hex 125mm (357.398, lot unknown, quantity 1), ratchet wrench-11mm width across flats (321.20, lot unknown, quantity 1).This is report 2 of 2 for complaint (b)(4).

• Brand Name: 10MM TI CANNULATED TIBIAL NAIL-EX/360MM-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: 7222839
• Report Number: 2939274-2018-50411
• Device Sequence Number: 14021741
• Product Code: JDS
• UDI-Device Identifier: 10886982084231
• UDI-Public: (01)10886982084231(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.004.452S
• Device Catalogue Number: 04.004.452S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2017
• Initial Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR