MAUDE Adverse Event Report: SYNTHES USA; ROD, FIXATION, INTRAMEDULLARY

Device Problems Difficult to Remove (1528); Unintended Movement (3026)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.Date of event: unknown.This report is for two unknown solid titanium tibial nails/unknown lots.Part and lot numbers are unknown; udi number is unknown.Implant date: unknown.Only the right nail was removed during the revision procedure on (b)(6) 2016; the left nail remains implanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).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

Device report from synthes (b)(4) reporting the following event: the patient underwent a bilateral removal of a solid titanium tibial nail system on (b)(6) 2016.The nails were migrating into the joint surface and the surgeon decided the remove the hardware once the injury had healed.Due to bony ingrowth, it was very difficult to remove the right nail.As a result, it took approximately one and a half (1.5) hours to take the nail out.The surgeon tried to remove the left nail but decided against it because it would not budge and had left it implanted.Postoperative patient outcome is stable.It is unknown when the patient was implanted with the hardware.This report is for the need for a revision procedure.This complaint is linked with (b)(4) which captures an intra-operative event during the revision procedure.Concomitant devices reported: titanium end cap (part unknown, lot unknown, quantity unknown), titanium locking bolt (part unknown, lot unknown, quantity unknown), titanium locking screw (part unknown, lot unknown, quantity unknown).This report is for two unknown solid titanium tibial nails.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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

Additional information was received on august 24, 2016 further reporting that the allotted surgical time for the procedure was two (2) hours.

• 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: 5903152
• MDR Text Key: 52949639
• Report Number: 2520274-2016-14340
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 08/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN QUANTITY UNKNOWN TITANIUM LOCKING SCREW
• Patient Outcome(s): Required Intervention