MAUDE Adverse Event Report: SYNTHES ELMIRA TFNA HELICAL BLADE 75MM STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.275S

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient identifier, date of birth, and weight not available for reporting.(b)(4).Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Dhr review for part # 04.038.275s lot # 9962653, release to warehouse date: 04 february 2016, expiration date: 01 january 2026, manufacturing site: (b)(4).Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna helical blade 75 mm 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.Product was not returned.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Dhr record review: a review of the device history record revealed no complaint related anomalies.X-ray review: on the provided x-rays it is visible that the blade cut out like reported.Complaint is therefore confirmed.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

Device report from synthes europe reports an event in (b)(6) as follows: the reported devices were used in the surgery for the femoral trochanter fracture on (b)(6) 2017.It was found on (b)(6) 2017 that there was a cut-out.The reduction and fixation for the intramedullary nail were performed by using the k-wire anteriorly.The set screws were finally tightened by using the t-shape torque wrench with a 1/4 rotation back, having its sliding mechanism allowed.Although the reduction was not sufficient, the blade itself did not have the sliding mechanism at all; therefore, the head of the femur became shortened.The medical follow-up had been done so far.If the patients some pain due to the progression of the blade cut-out, the re-operation (the blade replacement or the bha) will be considered.Patient had no pain.The patient is currently in the nursing home and barely walks.The initial surgery was extended for 15 minutes.Concomitant devices reported: end cap for tfna 0 mm (04.038.000s, lot l243179, quantity 1), 10 mm 125 degree cannulated tfna 200 mm (04.037.013s, lot 9859874, quantity 1), 5.0 mm locking screw with t25 stardriver 36 mm for im nail (04.005.526s, lot l019547, quantity 1).This report is for one (1) tfna helical blade 80 mm.This is report 1 of 1 for (b)(4).

• Brand Name: TFNA HELICAL BLADE 75MM 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: 7045181
• MDR Text Key: 92517759
• Report Number: 3003506883-2017-10273
• 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: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.275S
• Device Lot Number: 9962653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: END CAP (04.038.000S, LOT L243179, QTY 1); LOCKING SCREW (04.005.526S, LOT L019547, QTY 1); TFNA NAIL (04.037.013S, LOT 9859874, QTY 1)
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR