MAUDE Adverse Event Report: SYNTHES BETTLACH EXTRACTION SCREW FOR PFNA BLADE; EXTRACTOR

Catalog Number 356.825

Device Problem Mechanical Jam (2983)

Patient Problem Arthritis (1723)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: a manufacturing evaluation was completed: the extraction screw (356.825) and the blade (456.765) are jammed together.There are heavy marks on both instruments visible, especially at the shaft of the blade.Also we found that the cutting edges are blunt.The manufacturing review, of both devices, shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Unfortunately we cannot determine the exact root cause.It is likely that the jamming is a result of an mechanical overload situation during use and the heavy marks at the blade, were caused by a forceps or a similar instrument, therefore it is likely that the device was subjected to an inappropriate use.The relevant dimensions cannot be investigated, because the device can only be disassembled by destruction.Based on the investigation results, we consider this complaint as invalid from a manufacturing standpoint.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.

Event Description

It was reported that during a revision procedure, a blade would not detach from an extraction device.The procedure involved the removal of a previously implanted hip nail with a revision to a total hip replacement.The patient had the original surgery in europe.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.No non-conformance 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.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: EXTRACTION SCREW FOR 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: 4252417
• MDR Text Key: 12640606
• Report Number: 9612488-2014-10515
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.825
• Device Lot Number: 2193852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2014
• Initial Date FDA Received: 11/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2006
• 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
• Patient Outcome(s): Required Intervention