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

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient weight is unknown.510k: one (1) unknown tfna nail long sterile /unknown lot.Part and lot number are unknown; udi number is unknown.Explant date is unknown.Complainant part is expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.Post-operative x-rays taken on an unknown date during patient follow up revealed that the locking mechanism in the nail had failed to lock causing the helical blade to migrate or slide out of its intended location and the entire construct collapsed.The patient may require a revision surgery.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 a tnfa (trochanteric fixation nail-advanced) nail failed postoperatively.It was further explained that the nail, unknown helical blade and distal locking screw (quantity unknown) were originally implanted on (b)(6) 2017 and post-operative x-rays taken on an unknown date during patient follow up revealed that the locking mechanism in the nail had failed to lock causing the helical blade to migrate or slide out of its intended location and the entire construct collapsed.Reportedly, nail was locked per procedure using a torque limiting guide and x-rays taken right after the surgery showed the construct locked in the proper location and that the locking mechanism in the nail appeared to be down.The patient may require a revision surgery.All available information has been reported.Should the patient be revised the construct will be returned for investigation.The x-rays taken during follow up showing the failed nail and collapsed construct are available for investigation.Concomitant devices reported: distal locking screws (part # unknown, lot # unknown, quantity unknown).This report is for 1 unknown tfna nail long sterile.(b)(4).

Manufacturer Narrative

Date of event is unknown.It is unknown if the patient underwent revision surgery.Device was not explanted at the time of reporting.Device is not expected to be returned for manufacturer review/investigation.Based on the returned x-rays it was confirmed that the helical blade has migrated with respect to the nail.The condition of the locking mechanism could not be determined based on the x-rays.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.

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6981218
• MDR Text Key: 90395513
• Report Number: 2520274-2017-12535
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• 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
• Date Manufacturer Received: 12/01/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR