MAUDE Adverse Event Report: SYNTHES TUTTLINGEN ROD CUTTER; CUTTER, WIRE

Catalog Number 388.720

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information is unknown.Event date: unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 (b)(4) reports an event in (b)(6) as follows: it was reported that upon use, part of the cutting blade fragmented off.The device was not able to be used.It happened during surgery but there was no prolongation.This is report 1 of 1 for (b)(6).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Manufacturing date: 03 june 2009.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.

Manufacturer Narrative

A product investigation was completed: our investigation has shown that a round shaped piece at both blades of the bolt cutter is broken off.The manufacturing documents were reviewed and no complaint related issues were found.The lot in question was manufactured in the year 2009 according to the specification.The intact part of the cutting blades show slight wear marks, which can be expected at a bolt cutter that was used over several years.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances.There was no information about the cutting procedure provided, which makes it impossible to determine the exact cause of this occurrence.However, we were able to reproduce the same kind of damage during a performed test with a new bolt cutter, by cutting an extra-hard cobalt-chromium rod.With this type of rod the new bolt cutter was damaged in the same manner after one cut.In this relation we would like to point out that this device is not suitable for cutting cobalt-chromium alloys.For cutting this kind of rods the uss rod cutting and bending device must be used.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: ROD CUTTER
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5150580
• MDR Text Key: 28300977
• Report Number: 9680938-2015-10097
• 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: Other
• Type of Report: Followup,Followup
• Report Date: 09/25/2015

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: 388.720
• Device Lot Number: T938107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/03/2015; 12/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2009
• 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