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

Device Problems Bent (1059); Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Sedation (2368); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).(b)(4).Original implant date unknown.Not explanted, nail remains in patient leg.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Subject device has not been received.Without a lot number, the device history record review and 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

It was reported the patient experienced another fracture, at the previously treated fracture site with a nail, due to trauma.The patient was initially implanted with lateral entry femoral nail on an unknown date.The patient then had a motorcycle accident and fractured the distal third part of the femur around the nail.The surgeon intended to remove the synthes nail and insert a competitor's retrograde nail.The surgeon removed the interlocking screws and connected a non-synthes conical nail extractor to the nail.He attempted to back slap it multiple times and was unsuccessful at extracting the nail.He then decided that the only option was to re-insert interlocking screws and complete surgery.It was determined the nail was bent during the accident which would not permit it to be extracted.Patient outcome: the nail remained in the patient and leg mal-aligned.There was a 30 minute surgical delay.Surgery completed successfully.This complaint is for 1 device.Concomitant devices: unknown screw (part unknown, lot unknown, quantity unknown).This report is 1 of 1 for (b)(4).

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5644813
• MDR Text Key: 44886355
• Report Number: 2520274-2016-12626
• 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
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• 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: 04/22/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 110