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

Catalog Number 03.010.410

Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Report from synthes (b)(4) reports an event in (b)(6) follows: it was reported that the surgeon was trying to place an implant when the blue part of the instrument detached.In order to complete the operation, he had to use a clamp to be able to finish the intervention.There was a prolongation of surgery, however the exact time is unknown.There was no patient harm.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information not reported.Event date: unknown.Device is an instrument and is not implanted/explanted.The 510k#: device is not distributed in the united states, but is similar to device marketed in the usa.The device was received, an investigation summary was performed.Visual inspection: welding between the handle and the inner shaft, hammer marks visible the investigation of the complaint articles has shown that: the returned impactor presents a broken welding between the handle and the inner shaft.Based on these findings we have to assume that heavy strokes on the impactor caused the breakage of the welding seam.Please note, the current surgical technique recommends inserting the pfna blade by applying only gentle blows with the hammer.Device history records was conducted.The report indicates that: the review of the production history revealed that this instrument was manufactured in october 2013 according to the specifications.No manufacturing related issues that would have contributed to this complaint were found.No manufacturing related failure could be detected, no indication for material or design related issue.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: 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 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: 4644551
• MDR Text Key: 5678758
• Report Number: 9612488-2015-10207
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2015

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: 8584178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2015
• Initial Date FDA Received: 03/31/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2013
• 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