MAUDE Adverse Event Report: SYNTHES BETTLACH LOCKING CALCANEAL PLATE CUTTER; INSTRUMENT, CUTTING, ORTHOPAEDIC

Catalog Number 329.151

Device Problems Break (1069); Material Fragmentation (1261); Detachment of Device or Device Component (2907)

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

Event Date 06/25/2014

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).(b)(4).Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.A manufacturing investigation was also performed for the subject device.The plate cutter was received with surface scratches.Visible wear and tear marks were seen on the cutter and the edges of the cutter are rounded.The plate holder is broken off and was not returned for investigation.The laser etching is readable.The device was produced and distributed on november 2008.The manufacturing review shows that the production procedure was according to the specifications.Based on the received information the exact root cause cannot be determined.It is likely that the plate was not correctly inserted into the plate cutter.Due this situation the execution of the cutting process could not be performed because a higher force application was needed.Therefore the force was not allocated as intended, which could lead to the complained issue.The fracture face is homogenous, which indicates material conformity as well.The relevant dimensions could not be checked due to the bad condition of the part.The damage to the device was caused post-manufacturing.The complaint condition is confirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the locking calcaneal plate cutter broke while attempting to cut a plate intraoperatively on (b)(6) 2014.The cutter broke outside of the sterile field.The surgeon successfully made the first cut but he reported that the cutter felt different.When attempting to make the second cut it felt wobbly and the bottom metal head portion came off.The surgeon bent the plate at the indentation, the cutter left before it broke and he was able to cut the plate without the cutter.The rivet on the jaw portion of the cutter was loose.The procedure was completed successfully without patient harm or delay in the procedure.This report is 1 of 1 for (b)(4).

• Brand Name: LOCKING CALCANEAL PLATE CUTTER
• Type of Device: INSTRUMENT, CUTTING, ORTHOPAEDIC
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5272141
• MDR Text Key: 32865125
• Report Number: 9612488-2015-10612
• Device Sequence Number: 1
• Product Code: HTZ
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 329.151
• Device Lot Number: 2431474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2008
• 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
• Patient Age: 20 YR