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

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for unknown sliding hip screw system and the proximal femoral nail antirotation system.Unknown quantity/unknown lots.Udi: unknown part number, udi is unavailable.(b)(4): blade cut-out 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: bajpai, jeetendra, rajesh maheshwari, akansha bajpai, and sumit saini."treatment options for unstable trochanteric fractures: screw or helical proximal femoral nail." chinese journal of traumatology 18 (2015): 342-46.China.A total of 164 consecutive patients presenting a closed unilateral pertrochanteric fracture were enrolled.The patients were treated with a sliding hip screw or an intramedullary nail.The sliding hip screw system was used for extramedullary fixation of the stable fractures, whereas the proximal femoral nail antirotation (pfna) was used for intramedullary fixation.Mechanical failure (mf) was defined mf as loss of fracture reduction, screw or blade cut-out, lateral migration of the screw or blade, and implant breakage.There was an 81 year old female with a lateral blade migration.Since the the specific implants were not identified, it cannot be distinguished as to which group the malfunction belongs to.This report 4 of 4 for (b)(4).This report is for unknown sliding hip screw system and the proximal femoral nail antirotation system.

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5789743
• MDR Text Key: 49388622
• Report Number: 2520274-2016-13457
• Device Sequence Number: 1
• Product Code: JDS
• 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: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• 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: 07/07/2016
• 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: 81 YR