MAUDE Adverse Event Report: SYNTHES BETTLACH SMALL WIRE CUTTER 160MM; CUTTER, WIRE

Catalog Number 391.900

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Implant and explant dates: device is an instrument and is not implanted/explanted.Complainant device is not expected to be returned for manufacturer review/investigation.Initial reporter phone number is (b)(6).Device history record (dhr) review is not possible as reported serial number # (b)(4) does not match to article number (b)(4).Without a valid serial/lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the tip of the wire cutter broke.No surgical delay is reported.It is unknown if the wire cutter broke intra-operatively or pre-operatively.Concomitant reported part: wire (part # unknown, lot # unknown, quantity 1).This report is for one (1) small wire cutter 160mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: SMALL WIRE CUTTER 160MM
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6941419
• MDR Text Key: 90312378
• Report Number: 9612488-2017-10514
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 07611819024762
• UDI-Public: (01)07611819024762
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2017

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: 391.900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 10/11/2017
• 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