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

Catalog Number 388.72

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported one of the tips of the rod cutter broke from what was thought by the complainant to be due to normal wear and usage for over two years.There was no reported patient or procedure harm noted.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.(b)(6).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 raw material which was delivered as lot #00084433/4/5 is corresponding to the specifications.The hardness was measured at the time of the manufacturing between (b)(4) for carbide.Both were found to be conforming.No non-conformance reports were generated during production.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: a manufacturing evaluation was performed for the subject device.The subject device was received with one of the two jaws sheared off at the tips.A small piece was broken off.The complaint condition of ¿rod cutter broke¿ was confirmed.The manufacturing evaluation revealed there were no issues during the manufacture of the product that would contribute to this complaint condition.The hardness was measured by the vendor at 59 hrc but cannot be confirmed by the manufacturing site as the device has been returned to the synthes complaint handling unit.The device must be returned to synthes (b)(4) for additional evaluation if the actual hardness of the jaw is required.However the pictures are very consistent to cutting the wrong rods (ie cocr rods).The cutters are only to be used with titanium rods.It is likely that the root cause was incorrect usage of the cutters; however, the root cause could not be determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: a manufacturing investigation was conducted.The report indicates that the manufacturing evaluation shows that there were no issues during the manufacture of the product that would contribute to this complaint condition.Too much force or too many cuts caused the jaw to shear off.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 7853 2; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4098592
• MDR Text Key: 4701977
• Report Number: 9680938-2014-10061
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2014

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: 388.72
• Device Lot Number: T967029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2015
• Initial Date FDA Received: 09/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/24/2015; 03/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2011
• 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