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

Catalog Number 03.010.410

Device Problem Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Device is not distributed in the united states, but is similar to device marketed in the usa device is an instrument and is not implanted/explanted.(b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that: part: part: 03.010.410 lot: 9360646, manufacturing location: (b)(4) - manufacturing date: 18.May 2015.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the blue plastic handle of an impactor for proximal femoral nail antirotation (pfna) blades has loosened from shaft.It is visible that the welding seam is broken.The cleaning process was postoperative.The welding seam between blue handle and shaft is broken.The issue was detected during cleaning process, therefore no patient involvement.Complaint involves one (1) part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product investigation was completed for part # 03.010.410, lot # 9360646.The investigation has shown that the welding between the handle and the shaft is broken.The review of the production history revealed that this instrument was manufactured in accordance with the specifications.No manufacturing related issues that would have contributed to this complaint were found.At the head end there are strong impact marks visible.Based on these findings we have to assume that excessive strokes on the impactor have caused the breakage of the welding seam.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: EXTRACTOR
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6075467
• MDR Text Key: 59074031
• Report Number: 9612488-2016-10445
• Device Sequence Number: 1
• Product Code: HWB
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2016

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: 9360646
• Other Device ID Number: (01)07611819349476(10)9360646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 11/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2015
• 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