MAUDE Adverse Event Report: SYNTHES BETTLACH IMPACTOR F/PFNA BLADE

Catalog Number 356.823

Device Problem Mechanical Jam (2983)

Patient Problem Sedation (2368)

Event Date 03/11/2014

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that on (b)(6) 2014, a long (b)(4) proximal femoral nail was used for a femoral subtrochanteric fracture case.During drilling, the reamer interfered with the guide wire and broke off from the root.The blade was inserted without the guide wire.Checked by the image, the blade was not seated in the optimum position.The surgeon tried to extract the blade, but could not.The blade was finally extracted by removing the whole device.The blade and the impactor got stuck and could not be separated.Eventually another size blade was inserted using an extraction screw.It was also reported that there was a two hour surgical delay.This report is 2 of 4 complaint (b)(4).

Manufacturer Narrative

Device used for treatment, not diagnosis device is an instrument and is not implanted/explanted.Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.A review of the device history records was performed and no complaint related issues were found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A product development evaluation was completed: article 356.823 showed visible signs of use.The coated surface in the handle has been worn away to expose the metal surface under.Also there is evidence the handle has been struck by a hammer as intended indicating the instrument has been used repeatedly.There are also visible notches near the thread.There is no visible evidence of a defect in article 356.823.The part was used with two equivalent implants (art.04.027.035 lot 2679833 and art.04.027.059 lot 2535561) and the instrument still functioned as intended.The implant locking mechanism no longer functioned properly.Most likely the insertion tool was over tightened on the implant; however that cannot be verified.The surgical technique guide warns against over tightening.Additionally the technique guide was not explicitly followed.There are no issues with the insertion instrument (356.823).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: IMPACTOR F/PFNA BLADE
• Type of Device: IMPACTOR
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3724768
• MDR Text Key: 18366647
• Report Number: 9612488-2014-10084
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.823
• Device Lot Number: 2296957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention