MAUDE Adverse Event Report: SYNTHES BETTLACH EXTRACTION BOLT FOR 6.5MM & 7.0MM SCREWS; EXTRACTOR

Catalog Number 309.069

Device Problem Break (1069)

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

Event Date 10/09/2014

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: an evaluation was performed on the returned device.As per received condition of device; an extraction bolt was received.The returned device shows significant use during its lifespan.The devices have significant scratches and marks from regular use.The tips of both devices were broken off.It appears that the devices were subjected to lateral forces outside of recommended usage.Additionally, the returned devices broke while they were being used to remove non-synthes implants.The drawing was reviewed.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.The returned instrument is used to remove broken screws and proper use and maintenance are addressed in technique guides.It appears that the devices were subjected to lateral forces outside of recommended usage, which led to the breakage.Additionally, the returned devices broke while they were being used to remove non-synthes screws.The complaint condition was caused by method of use and off axis use, rather than the design of the instrument.This complaint condition is likely a result of method of use and off axis use, and not the device's design.Because of this, the complaint is determined not to be a result of a detected design deficiency.The returned part is determined to be suitable for their intended use when used and maintained as recommended.This complaint is confirmed, but the design of the device did not contribute to this complaint.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 an external fixator removal procedure on (b)(6) 2014 the surgeon was attempting to try and remove a non-synthes pin from the femur and four instruments were damaged during the attempted removal.The broken pin was eventually removed with vice grips without patient harm or surgical delay.Two of the devices were returned and it was discovered that the tip broken off of both of them.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 BOLT FOR 6.5MM & 7.0MM SCREWS
• 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: 4261119
• MDR Text Key: 15287748
• Report Number: 9612488-2014-10497
• 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: 11/06/2014

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: 309.069
• Device Lot Number: 2542563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 11/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2009
• 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