MAUDE Adverse Event Report: SYNTHES BALSTHAL 2.0MM MLP BENDER/CUTTER; INSTRUMENT, BENDING OR CONTOURING

Catalog Number 329.143

Device Problem Break (1069)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2014

Event Type  malfunction  

Event Description

Device report is from synthes (b)(4) reporting an event in (b)(6).

Manufacturer Narrative

Additional narrative: the manufacturing documents were reviewed and no complaint related issues were found.A manufacturing evaluation was completed: the product was received with the bending nose of cutting/bending instrument broken off.The bending nose broke starting from the transition radius of the nose, crossing the central bore of the joint and terminating in the cutting feature of the instrument.The instrument was launched initially in 2002.In (b)(6) 2006 the design, especially the transition radius between the joint housing and nose was changed.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The cutting tip of the plier came off during cutting of a veterinary unilock plate 2.0.No excessive force was ued.No patient was involved.This report is 1 of 1 for (b)(4).

• Brand Name: 2.0MM MLP BENDER/CUTTER
• Type of Device: INSTRUMENT, BENDING OR CONTOURING
• Manufacturer (Section D): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH47 10; SZ CH4710
• Manufacturer (Section G): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH47 10; SZ CH4710
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3667617
• MDR Text Key: 4480738
• Report Number: 3009450863-2014-10002
• Device Sequence Number: 1
• Product Code: HXP
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2014

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: Other Health Care Professional
• Device Catalogue Number: 329.143
• Device Lot Number: 7802342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2014
• Initial Date FDA Received: 03/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2012
• 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