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 Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(4) as follows: it was reported that the blades are not removable from instruments, no surgical delay or procedure outcome was reported.It was reported that occurrence was not relevant to the health of patient.This is report 2 of 4 for complaint: (b)(4).

Manufacturer Narrative

Device was used for treatment, not for diagnosis.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Date on follow up number 2 should have been (b)(6) 2014.Device is not distributed in the united states, but is similar to device marketed in the usa.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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).An evaluation was performed on the returned device.As per received condition of the device; the blades are jammed/ not removable from the impactor.The complained blades and the impactor shows scratches and heavy wear and tear on the surface which can be referred to as forcible misuse with a forceps or a similar tool.The manufacturing review of both instruments shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Based on the received information it cannot determine the exactly root cause.The device was not used as intended which could cause the jamming of the devices.Please note that the impactor should be mounted in the clockwise direction to engage the blade.Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.No product fault could be detected.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: 3694556
• MDR Text Key: 4259111
• Report Number: 9612488-2014-10051
• 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,Followup,Followup
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2014
• 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: 2804428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2011
• 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