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

Catalog Number 388.72

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.The investigation could not be completed; no conclusion could be drawn as no product was received.A review of the service history records has been requested and is pending completion.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.

Event Description

It was reported that the jaws of two rod cutters are broken.The devices were reportedly used to open a locker by a member of the hospital's night staff.No surgical or patient involvement.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: service history review: part no: 388.72, lot no: t970320: no service history review can be performed as this is a lot controlled item.The manufacture date of this item is 06october2011.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed 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.

Manufacturer Narrative

Additional narrative: a service and repair evaluation was completed: the customer reported the jaws were broken.The repair technician reported the cutting jaws were damaged.Cutting jaws broken is the reason for repair.The cause of the issue is unknown.The evaluation was confirmed.A product investigation was completed: the instruments will be repaired when the replacement components arrive and will be returned to the customer.Based on the complaint description, a root cause related to off-label use was determined.No manufacturing or design issues were noted.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

Device was used for treatment, not diagnosis.Corrected data: the previously reported service and repair evaluation was updated for the subject device.The customer reported the jaws were broken.The repair technician reported the cutting jaws were damaged.Cutting jaws broken is the reason for repair.The cause of the issue is unknown.The following parts were replaced: jaw/bolt system.The item was repaired, passed synthes final inspection and returned to the customer on 31-dec-2015.The evaluation was confirmed.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: 5171783
• MDR Text Key: 29201406
• Report Number: 9680938-2015-10101
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/09/2015

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: 388.72
• Device Lot Number: T970320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2015
• Initial Date FDA Received: 10/23/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/12/2015; 12/09/2015; 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2011
• 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