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

Catalog Number 03.614.021

Device Problem Component Falling (1105)

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

Event Date 10/07/2015

Event Type  malfunction  

Manufacturer Narrative

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 the investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review ¿ manufacturing location: synthes (b)(4).Manufacturing date: 04/21/2009.Part #: 03.614.021, lot#: t934068 (nonsterile) - lot was release to the warehouse on 04/21/2009.Purchase order was released on 04/16/2009.No ncrs 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.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 a piece of a rod cutter came off during a posterior cervical fusion.Another rod cutter was available for use.No reported surgical delay, no fragments, no additional medical intervention.The procedure was completed without further incident.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; 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.

Manufacturer Narrative

Product investigation summary: the returned instrument was examined and the compliant condition was able to be confirmed as one of the cutting tips was returned broken at the pivot screw.The broken-off portion of the tip was returned.A definitive root cause was unable to be determined; however, the complaint condition is consistent with the application of excessive forces and/or improper technique.The rod cutter is a component of the synapse system, which is utilized for posterior stabilization of the upper spine.The rod cutter is specifically utilized to cut the rod to length prior to implantation.The returned instrument was examined and the compliant condition was able to be confirmed as one of the cutting tips was returned broken at the pivot screw.The broken-off portion of the tip was returned.The relevant drawings for the returned instrument were reviewed.The design, materials, and finishing processes were found to be appropriate for the intended use of these devices.A device history review was performed for the returned instrument¿s lot numbers and in each instance no material record reports, non-conformance reports, or complaint-related issues were identified.Device 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: 5165989
• MDR Text Key: 28863459
• Report Number: 9680938-2015-10099
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2015

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: 03.614.021
• Device Lot Number: T934068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2015
• Initial Date FDA Received: 10/21/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/06/2015; 12/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2009
• 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