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

Catalog Number 329.151

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: event date: unknown.Device is an instrument and is not implanted/explanted.A service and repair history record review was attempted for the subject device.The review could not be completed because the device is a lot-controlled item.The manufacture date of the subject device is oct 4, 2001.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.A service and repair evaluation was also performed for the subject device.The repair technician reported the cutting jaws were broken.¿cutting jaws broken¿ is the reason for repair; however, this item is not repairable.The cause of the issue is unknown therefore the item was forwarded to the complaint handling unit for additional investigation.The service and repair evaluation was confirmed.A product development investigation was performed for the subject device (locking calcaneal plate cutter, part 329.151).Upon visual inspection of the returned plate cutting instrument it was noted that the tension spring on the lower body of the instrument was missing and was not returned.Without the tension spring the instrument will not be able to function as intended as the component is required to provide tautness to enable it to cut/contour the plate.A definitive root cause could not be determined; however, it is possible that too much force was applied during manipulation of the plate, leading to the spring snapping.The technique guide and associated device drawing were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of the device.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 initially reported on (b)(6) that the plate cutter sheared during a sales training lab (not in the operating room).There was no patient or surgical involvement and the event was initially determined to be non-reportable.This plate cutter instrument is not used in the surgical field and is used at the back table of the operating room when used during surgery.The event was re-reviewed based new reportability criteria, effective on (b)(6) 2016, to include instruments found to have broken but for which there is no information regarding time and location of breakage, as being reportable for malfunction, regardless of negative product history for death or serious injury.Based on the (b)(6) 2016 reporting criteria this event was determined to be a reportable malfunction.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: 5442627
• MDR Text Key: 38411753
• Report Number: 9612488-2016-10089
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 329.151
• Device Lot Number: 4327753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2001
• 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