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

Catalog Number 03.010.410

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No known patient or surgical involvement.Exact date of device malfunction is unknown.Device is an instrument and is not implanted or explanted.(b)(6).Device is not distributed in the united states, but is similar to a device marketed in the us.Product investigation summary: the investigation has shown that the welding joint between the handle and the inner shaft (the piece of plastic handle) as well as the hexagon on the tip were broken.The broken fragments were not received with the device for investigation.The shaft is in good condition besides some slight scratches.The nature of the visible hammering marks, and striations on the striking head, point to the fact that the instrument was subjected to excessive use.The current technique guide recommends that the user insert the proximal femoral nail antirotation (pfan) blade to the stop by applying gentle blows with the hammer.The manufacturing review shows that the production procedure was according to the specifications and made in january, 2008.There were no issues that would contribute to this complaint condition.No product fault could be detected.The likely root cause was excessive force through the method of use and associated accumulations of damage and wear.No indication for product related issues were found.Device history record review: manufacturing location: (b)(4) - manufacturing date: january 4, 2008.No non-conformance reports 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.Device 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 originally reported that the handle of the impactor loosened from the shaft.No known patient or surgical involvement.During the initial visual inspection of the returned device, it was determined that the device had actually broken in two (2) spots.The device was, therefore, reassessed for reportability on march 18, 2016.(b)(4).

Manufacturer Narrative

Date was incorrectly entered on the initial medwatch.The correct date of awareness for the original event was january 28, 2016.This date has been updated in the appropriate field.Device 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 CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5519284
• MDR Text Key: 40932604
• Report Number: 9612488-2016-10154
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• 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: 8198345
• Other Device ID Number: (01)07611819349476(10)8198345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2008
• 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