MAUDE Adverse Event Report: SYNTHES USA 4.9MM TI LOCKING BOLT 40MM; PIN,FIXATION,SMOOTH

Catalog Number 459.400VS

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

Patient Problems Discomfort (2330); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: a proximal femoral nail antirotation (pfna) surgery had taken place on (b)(6) 2014.On (b)(6) 2015, the patient complained of ambulation difficulty and it was found via x-ray that the patient¿s implant migrated.On (b)(6) 2015, the surgeon performed extraction surgery of the implants and also performed a total hip arthroplasty.During surgery it was found that the patient had osteonecrosis of the femoral head, damage of ¿hip cut¿ and the implant had indeed migrated.This is report 2 of 4 for (b)(4).

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.Unknown when device migrated.Device returned to patient.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.Mfr date: unknown.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: it could not be confirmed exactly how this complaint occurred, device(s) not returned, no conclusion can be made.Dhr review could not be conducted due the insufficient information¿s.No further investigation possible as there was no material available because they were returned to the patient.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.

• Brand Name: 4.9MM TI LOCKING BOLT 40MM
• Type of Device: PIN,FIXATION,SMOOTH
• 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: 4905239
• MDR Text Key: 6536004
• Report Number: 2520274-2015-14872
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK970733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 459.400VS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2015
• 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: 80 YR
• Patient Weight: 60