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

Catalog Number 388.72

Device Problem Delamination (2904)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.No patient involvement reported.Event date: unknown.Implant and explant dates: device is an instrument and is not implanted/explanted.Date returned to manufacturer.Initial reporter facility phone number: (b)(6).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.A service & repair evaluation/review was attempted; no service history review can be performed as part number 388.72 with lot number(s) t970320 is a lot/batch controlled item.The manufacture dates of this item are 20-mar-2012 and 6-oct-2011.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Device history records review was conducted.The report indicates that: dhr review for: part 388.72, lot t970320, manufacturing date: 04-oct-2011.Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the components and final product met inspection records.All 38 parts of the lot were checked 100% for critical features and for function at the final inspection on 30-sep-2011.A service history evaluation/review was performed.The investigation of the complaint articles has shown that: (the customer reported the cutting jaw was chipped.The repair technician reported cutting jaws broken as the reason for repair.The cause of the issue is unknown.The following parts were replaced: jaw/bolt system.The item was repaired per the inspection sheet, passed synthes final inspection on 27-oct-2016 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.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.

Event Description

Device report from synthes on an event in (b)(6) as follows: (b)(6) reported the following: it was reported that the cutting jaw for a rod cutter is chipped and dented this was identified in the sterile processing department.There was no patient involvement or surgical procedure.This complaint involves one device.This report is 1 of 1 for (b)(4).

• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6104755
• MDR Text Key: 59979112
• Report Number: 9680938-2016-10172
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2016

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
• Other Device ID Number: (01)10705034773759(10)T970320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2011
• 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