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

Catalog Number 03.010.410

Device Problem Mechanical Jam (2983)

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

Event Date 03/01/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the pfna (proximal femoral nail antirotation) blade blocked in the impactor.The impactor and the pfna blade were sticking together.It was impossible to remove causing the breakage of the aiming arm and the protection sleeve due to overstraining.Another lfn (lateral femoral nail) was used for implantation.An undefined surgical delay was reported as a surgical delay (x4).This report is for 1 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

This device was used for treatment, not diagnosis.The manufacturing evaluation reports, the relevant dimensions at the impactor cannot be verified anymore as the blade is completely stuck on it and cannot be removed.This lot of (b)(4) pieces was manufactured in may 2013 and there are no other complaints for this article- and lot number.Therefore this evaluation is indeterminate from a manufacturing standpoint.There are clearly visible stress marks next to the ¿attach/lock¿ marking below the blue plastic handle visible.The marks are on opposite sides which indicates that a pliers was used to apply excessive force onto the impactor, but afterwards it cannot be defined if the was for loosening or tightening of the blade.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: 3735271
• MDR Text Key: 4225205
• Report Number: 9612488-2014-10086
• 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: 03/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.410
• Device Lot Number: 8392887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2014
• Initial Date FDA Received: 04/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2013
• 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