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

Catalog Number 04.038.400S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional device product code is ktt.(b)(4).The subject is not expected to be returned to the synthes manufacturer for evaluation.(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 subject device lot number.Manufacturing location: synthes (b)(4).Date of manufacture: jan 21, 2015.Expiration date: jan 1, 2025.The review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 10.5mm tfna fenestrated 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.However a rationale was written for an acceptable labeling discrepancy regarding company logo change from (b)(4).The label master document did not match the actual printed label.This resulted in no impact on mechanical properties, safety and efficacy of the product.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.(b)(4).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 reported an event in (b)(6) as follows: it was reported that revision surgery including removal of a trochanteric fixation nail advanced (tfna) nail and blade system was performed on (b)(6) 2017 due to pain, arthritis, and fibrous non-union (partial).The patient was revised to a total hip replacement.The surgeon did not attribute the patient¿s condition to the tfna implants and stated the main reason for the revision was the patient¿s arthritic hip and pain.There was no loosening or breakage of the tfna implants.The patient was initially implanted with the tfna nail and blade on (b)(6) 2016.This report is 2 of 2 for (b)(4).

• Brand Name: TFNA FENESTRATED 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: 6383017
• MDR Text Key: 69202455
• Report Number: 3003506883-2017-10032
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K160167
• 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: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.400S
• Device Lot Number: 7874396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention