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

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2017

Event Type  malfunction  

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 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
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7222839
• MDR Text Key: 98738525
• Report Number: 2939274-2018-50411
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982084231
• UDI-Public: (01)10886982084231(10)LOTNUMBERUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.004.452S
• Device Catalogue Number: 04.004.452S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21 YR