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

Catalog Number 356.823

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: while locking the blade, the distal portion of the impactor (colored portion) was loosened and detached from the remaining impactor.But the surgeon tried to lock the blade with the impactor through some other method which resulted in damage of the protection sleeve and drill sleeve.After the surgery, it was found that the drill sleeve is not completely inserting into the protection sleeve and it jams.This is report 1 of 3 for complaint (b)(4).

Manufacturer Narrative

Device used for treatment, not diagnosis.Device is an instrument and neither implanted nor explanted.Device is not distributed in the united states, but is similar to device marketed in the usa.No nonconformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The returned part was investigated.The tip of the impactor got bent then the end is completely broken off.The handle is also quite worn indicating it had been used a considerable number of times.The shaft also shows signs of a lot of wear and usage.It is also marked as a loan instrument which further points to it being used in a lot of surgeries.The technique guide was referenced and there is a note stating ¿do not use unnecessary force when inserting the proximal femoral nail anti-rotation blade¿.Based on the age (manufactured march 2009) and examination of the article we can state that this type of damage is from a combination of mishandling and wear and tear and there is no inherent product fault.The drill sleeve and protection sleeve were not returned for analysis but a review of the device history records confirm that these articles were manufactured in october and november 2011 meeting all specifications.We would like to point out that as per guide ¿if the pfna blade cannot be locked, remove it and replace it with a new pfna blade¿ but according to the complaint report, the surgeon used some other method (unknown) which resulted in breakage of protection and drill sleeve.A review of our complaints history for all of the above articles show there have been no other complaints from these article numbers and lot numbers.No product fault could be determined with returned article.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: 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: 3904646
• MDR Text Key: 4675279
• Report Number: 9612488-2014-10256
• 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
• Report Date: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.823
• Device Lot Number: 2464372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2009
• 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