MAUDE Adverse Event Report: SYNTHES (USA) TIB-NAIL F/SHAFT FRACT 10 CANN L330 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.035.033

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 08/28/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).(b)(6).Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.Device is not distributed in the united states, but is similar to device marketed in the usa.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 Description

Device report from synthes (b)(6) reported an event in (b)(4) as follows: it was reported that during a tibia nailing procedure, when the nail had been inserted into the patient and the surgeon was trying to remove the synthes guide wire, the ball tip of the guide wire wasn't able to pass through the tibia nail.It seemed like something stuck inside the cannulated nail and it was blocking the ball tip of the guide wire.The surgeon had to take out the tibia nail together with the guide wire and reinsert another nail (competitor's device).The surgery was delayed one (1) hour due to the reported event.This report is 1 of 1 for (b)(4).

• Brand Name: TIB-NAIL F/SHAFT FRACT 10 CANN L330 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5961276
• MDR Text Key: 55096525
• Report Number: 2520274-2016-14581
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 04.035.033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ONE, UNKNOWN GUIDE WIRE
• Patient Outcome(s): Required Intervention