MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA-II BLADE L95 TAN; APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT

Catalog Number 04.027.054S

Device Problem Mechanical Jam (2983)

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

Event Date 06/30/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Udi: (b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Hospital contact telephone is not available for reporting device is not distributed in the united states, but is similar to device marketed in the usa.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Dhr review.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing location: (b)(4).Manufacturing date: 03.Apr.2017 expiry date: 01.Mar.2027.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 (b)(4) reports an event in (b)(6) as follows: it was reported during a procedure to repair a femoral trochanteric fracture on (b)(6) 2017, surgeon encountered difficulty inserting the proximal femoral nail-antirotation (pfna) blade.Surgeon turned the end of the pfna blade after it was connected to the impactor for pfna blade and heard a strange noise and felt slight resistance.Surgeon attempted to remove the pfna blade from the impactor by turning it clockwise.The pfna blade stopped in the middle and could not be detached.This was attempted several times.It was only when attempted with force that surgeon was able to detach the pfna blade from the impactor.Another pfna blade of a different size was used to complete the procedure with a delay of approximately 10 minutes.No harm to patient was reported.Concomitant devices reported: impactor for pfna blade (356.823, lot number unknown, quantity 1).This report is for one (1) pfna blade.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product development investigation was completed.Device was returned with slight visible scratches on the shaft.Threaded connection showed signs of usage.The locking mechanism was working as intended.A functional test with another inserter was performed to reproduce the complained issue.The blade passed the functional test successfully.The reported event of ¿could not be detached form the inserter¿ could not be duplicated.Without having the reported inserter back, it is not possible to determine the exact cause of the complained issue.It can be assumed that during the operation an application error may have taken place.Since no product fault related condition was detected, this complaint is unconfirmed.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.

• Brand Name: PFNA-II BLADE L95 TAN
• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6750319
• MDR Text Key: 82263390
• Report Number: 9612488-2017-10355
• Device Sequence Number: 1
• Product Code: KTW
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.054S
• Device Lot Number: L365872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1