MAUDE Adverse Event Report: SYNTHES HAGENDORF BOLT CUTTER HEAD FOR 5.0MM FIXATION PINS XL; CUTTER,WIRE

Catalog Number 391.771

Device Problem Break (1069)

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

Event Date 09/23/2015

Event Type  malfunction  

Manufacturer Narrative

Additional product codes ¿ htz, fzt.Device is an instrument and is not implanted/explanted.(b)(6).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

Device report from synthes eu reports an event in (b)(6) as follows: during surgery it was found that the tip of the bolt cutting head was cracked.The surgery was not prolonged.There is no additional information at this time.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Manufacturing location: (b)(4).Manufacturing date: 13august2007.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 there was no patient harm; all broken off pieces were removed from the patient.

Manufacturer Narrative

A product investigation was completed: the device was received with the bottom of the cutting head partially broken.The product was produced in august 2007.The instrument was disassembled.Several traces of mechanical damages found on the device.The microscopic view of the broken surface shows a homogenous surface what indicates material conformity.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Unfortunately we only have limited information in the complaint description and cannot confirm how this happened.Based on the investigation results it is likely that the cause of the breakage is the result of a mechanical overload situation during use.Because of the damage, the complaint relevant dimensions cannot be checked.It is very important that the schanz screw is positioned correctly before cutting and that very fast cutting-procedures may lead to a short time overloading resulting in the breakage of the bottom of the cutting head.No product fault could be detected.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: BOLT CUTTER HEAD FOR 5.0MM FIXATION PINS XL
• Type of Device: CUTTER,WIRE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf PA CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5128118
• MDR Text Key: 27489847
• Report Number: 2520274-2015-16445
• Device Sequence Number: 1
• Product Code: HXZ
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Followup,Followup
• Report Date: 09/23/2015

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: 391.771
• Device Lot Number: 1724704
• Other Device ID Number: (01)07611819112216(10)1724704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/15/2015; 01/18/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2007
• 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