MAUDE Adverse Event Report: SYNTHES USA TFNA HELICAL BLADE/TFN ADVANCED FEM NAIL; ROD,FIXATION,INTRAMEDULLARY

Device Problem Migration or Expulsion of Device (1395)

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

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.This report is for unknown tfna helical blade l/unknown lot number.Partial part #04.038.Xxx tfna helical blade l.Concomitant device: 1x unk tfn advanced fem nail (04.037.Xxx).(b)(4) the complaint indicated that this blade migrated post-op which likely will require additional surgical intervention.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

Device report from synthes on an event in (b)(6) as follows: it was reported that the reported device was used in surgery for the femur trochanteric fracture, but the surgery date is unknown.According to the surgeons comment, the blade rotated after the surgery.This complaint involves 1 part.Concomitant device: 1x unk tfn advanced fem nail (04.037.Xxx).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(6).Part number is unknown; exact brand name is unknown.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 concomitant parts reported: tfna implant set for locking screw 5.0mm (part 005.Set, lot unknown, quantity 1); tfna end cap 0mm (part 04.038.000s, lot unknown, quantity 1) the provided x-rays were reviewed by the manufacturer and it was noted no blade rotation could be confirmed but there seems to be a loss of reduction.

• Brand Name: TFNA HELICAL BLADE/TFN ADVANCED FEM NAIL
• 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: 6097100
• MDR Text Key: 59715442
• Report Number: 2520274-2016-15363
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• 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?: Yes
• Date Manufacturer Received: 11/10/2016
• 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: 1X UNK TFN ADVANCED FEM NAIL
• Patient Outcome(s): Required Intervention