MAUDE Adverse Event Report: UMKIRCH FRONT CUTTER; CUTTER,WIRE

Catalog Number 03.607.513

Device Problem Break (1069)

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

Event Date 10/05/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient age, dob & weight not provided for reporting.Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional is obtained that was not available for the initial med-watch, the investigation will be updated as applicable, and a follow-up med-watch will be filed as appropriate.Report was initially submitted on oct 30, 2017, but the fda site was down.Advised by fda on nov 6, 2017 to resubmit medwatch.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: it was reported that a front cutter broke during a procedure.There was no patient harm for this case.The patient status was reported to be good.There was no surgical delay.This complaint involves 1 device.This report is 1 of 1 for (b)(4).

• Brand Name: FRONT CUTTER
• Type of Device: CUTTER,WIRE
• Manufacturer (Section D): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• Manufacturer (Section G): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7003659
• MDR Text Key: 92211742
• Report Number: 3003862213-2017-10022
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2017

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: 03.607.513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2017
• Initial Date FDA Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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