MAUDE Adverse Event Report: SYNTHES MONUMENT WIRE CUTTER 220MM; CUTTER,WIRE

Catalog Number 391.93

Device Problems Dull, Blunt (2407); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There was no known reported patient involvement associated with the complained event.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.No service history review can be performed as part number 391.93 with lot number(s) a7ka51/4360589 is a lot/batch controlled item.The manufacture date of this item is 2-jan-2002.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Device history review for part # 391.93, supplier lot # a7ka51, synthes lot # 4360589 concluded that no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition and release to warehouse date is (b)(6) 2002 and supplier is (b)(6).Service evaluations concluded that the customer reported the inserts were chipped.The repair technician reported the cutting inserts/jaws were chipped and broken.Cutting jaws broken is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.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.

Event Description

The service & repair department documented that the facility reported the inserts are chipped.The facility reported that it looked like they were used to cut something they were not intended to be used for.The device was discovered in sterile processing; there was no patient involvement.During manufacture service evaluation process it was identified that that the cutting inserts/jaws were chipped and broken.This complaint condition was re-evaluated and was determined to be reportable on (b)(6) 2016.This is report number 1 of 1 for complaint (b)(4).

Manufacturer Narrative

The manufacturer investigation results are as follows.The device was returned and reported to have become chipped.This condition is confirmed; there are two chips on both cutting edges approximately two millimeters wide and one millimeter deep.It is likely that over fourteen years of consistent use has led to this complaint condition.The device was manufactured in 1/2002 and is over fourteen years old.The balance of the returned device is in fairly worn condition with several markings and other signs of wear along its length.Drawing were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.Upon review of the device history record, no ncrs germane to the complaint condition were generated during the production of this device.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: WIRE CUTTER 220MM
• Type of Device: CUTTER,WIRE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6156351
• MDR Text Key: 61903345
• Report Number: 1719045-2016-10898
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 10/24/2016

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: 391.93
• Device Lot Number: 4360589
• Other Device ID Number: (01)10886982198440(10)4360589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 12/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/21/2016; 12/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2002
• 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