MAUDE Adverse Event Report: SYNTHES USA; SCREW, FIXATION, BONE

Device Problem Difficult To Position (1467)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Reynders, p.And broos, p.(2000).Healing of closed femoral shaft fractures treated with the ao unreamed femoral nail.A comparative study with ao reamed femoral nail.Injury, international journal of the care of the injured, 367-371.This report is for an unknown locking acrews/unknown quantity/unknown lot.(other number) udi: unknown part number, udi is unavailable.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the subsequent review of the following literature article: reynders, p.And broos, p.(2000).Healing of closed femoral shaft fractures treated with the ao unreamed femoral nail.A comparative study with ao reamed femoral nail.Injury, international journal of the care of the injured, 367-371.Belguim.This study summarizes the clinical experiences of healing time with the unreamed femoral nail (ufn) group compared to the reamed femoral nail (rfn) group in one hundred and seven closed femoral fractures.Fifty three patients were treated with the ufn and fifty-four were treated with the rfn.Mean patient age for the rfn group was 30.7 years and 34.4 years for the ufn group.Complications included: two (2) unknown locking screws that were difficult to lock and nicked the nail during surgery in a 22 year old male patient.This is report 2 of 5 for (b)(4).This report is for unknown locking screws.A copy of the article will be submitted with the medwatch,.

• Type of Device: SCREW, FIXATION, BONE
• 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: 5398222
• MDR Text Key: 37103651
• Report Number: 2520274-2016-10415
• Device Sequence Number: 1
• Product Code: HWC
• 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
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2016
• 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 Age: 22 YR