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

Catalog Number 03.010.410

Device Problem Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.There was no reported patient involvement associated with the complained event.Device is an instrument and is not implanted/explanted.(b)(6).This complaint was reassessed for reportability upon completion of the investigation on august 25, 2016.Device is not distributed in the united states, but is similar to device marketed in the usa.A product investigation was performed for the subject device.The investigation revealed that the welding joint between the handle and the inner shaft broke and therefore the plastic handle separated from the shaft.The handle is intact-- nothing has broken off.The nature of the visible hammering marks and striations on the striking head, and at the front side of the handle, show that the instrument has been subjected to excessive use.The current technique guide recommends ¿insert the pfna blade to the stop by applying gentle blows with the hammer¿.The device history record review shows that the device fully met fully specifications at the time of manufacturing in january 26, 2010 and there were no issues that would contribute to this complaint condition.The complaint condition is confirmed.The root cause was determined to be excessive, long term use.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) reported an event in (b)(6) as follows: it was reported that the handle of an impactor for proximal femoral nail antirotation (pfna) blades has loosened from shaft.The issue was detected during the postoperative cleaning process.There was no reported patient or procedural involvement; however, it is unknown when the device handle became loose.This report is 1 of 1 for com-(b)(4).

• Brand Name: IMPACTOR F/PFNA BLADE
• Type of Device: IMPACTOR
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5916233
• MDR Text Key: 53553353
• Report Number: 9612488-2016-10355
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/04/2016

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: 2554071
• Other Device ID Number: (01)07611819349476(10)2554071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2010
• 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