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

Catalog Number 388.72

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2014

Event Type  malfunction  

Event Description

It was reported that the rod cutter tips broke off after a surgeon attempted to use a rod cutter to cut tips off of a retractor that was trapped under implanted rods.The rod cutter tips were retrieved from patient and discarded.Surgery was complete successfully.No additional information will be made available.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn.A service history report has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional narrative: 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 service history maintenance review was performed.The investigation of the complaint articles indicates that the: lot #t938107 no service history review can be performed as this is a lot controlled item.The manufacture date of this item is 11-jun-2009.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.A service history eval was performed.The investigation of the complaint articles has shown that: the customer reported the tips were broken.The repair technician reported the cutting jaws were broken.Cutting jaws broken is the reason for repair.The cause of the issue is unknown.The following parts were replaced: jaw/bolt system.This item was repaired, passed final inspection and returned to the customer on 9-dec-2014.The evaluation was confirmed.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: 4309225
• MDR Text Key: 5210698
• Report Number: 9680938-2014-10094
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2014

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: T938107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 12/09/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/06/2015; 01/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2009
• 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
• Patient Age: 61 YR
• Patient Weight: 112