MAUDE Adverse Event Report: SYNTHES ELMIRA TFNA HELICAL BLADE 100MM STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.038.300S

Device Problems Fitting Problem (2183); Device Operates Differently Than Expected (2913)

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

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information is not available for reporting.Other number¿udi: (b)(4).The subject device is not expected to be returned to the synthes manufacturer for evaluation.Reporting facility phone number is (b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the reported subject device lot.Manufacturing location: (b)(4).Date of manufacture: mar 30, 2016.Expiration date: mar 1, 2026.The review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna helical blade 100mm sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes europe reported an event in (b)(6) as follows: it was reported that during surgery to implant a trochanteric fixation nail anitrotation (tfna) nail, tfna blade, unknown end cap, and unknown screw on (b)(6) 2017 to treat a trochanteric femoral fracture, even though a ¿click¿ sound could be heard, the locking mechanism could not be locked.The surgeon was able to insert the end cap and the hardware was left in the patient.There was a surgical delay of unknown duration due to the reported event.The patient¿s postoperative outcome is unknown.Concomitant part: 1 x end cap, part: unknown.This report is 2 of 2 for (b)(4).

• Brand Name: TFNA HELICAL BLADE 100MM STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6530519
• MDR Text Key: 74090812
• Report Number: 3003506883-2017-10066
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131548
• 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
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.300S
• Device Lot Number: 9982093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN END CAP, QTY. 1