MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SHORTCUT PLATE CUTTER FOR 2.4MM PLATES & THORP; INSTRUMENT,CUTTING,ORTHOPAEDIC

Catalog Number 391.967

Device Problem Break (1069)

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

Event Date 10/31/2017

Event Type  malfunction  

Manufacturer Narrative

Patient weight was not provided for reporting.Udi# (b)(4).Implant and explant dates: incident occurred intraoperative.Device was not implanted/explanted.Initial hospital reporter contact number was not provided for reporting.The device was received and the product evaluation is in progress.No conclusion can be drawn.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

It was reported that on (b)(6) 2017, patient underwent treatment for a bilateral mandible fracture.During the surgery, the handle of the plate cutter shattered in surgeon¿s hand while being used to cut a 2.4 locking recon plate.Reportedly, the surgeon was cutting the 2.4 locking recon plate at the surgical table away from the patient.A backup was made available immediately and the surgery was completed with no delay.There was no reported harm to the patient.The surgery outcome was successful and the patient was reported to be in stable conditions following the procedure.Concomitant device reported: plate mandible locking (part# unknown, lot# unknown, quantity 1).This report is for one (1) shortcut plate cutter for 2.4mm plates & thorp.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product development investigation was completed.The returned device was examined and the complaint condition was able to be confirmed as the device¿s phenolic handle was found to be broken into four pieces at the cross-pin.The shortcut plate cutter for 2.4mm plates and thorp (391.967) is available in the 2.0mm mandible locking plate system to cut plates to fit patient anatomy.Relevant drawings for the returned device were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of this device.No dimensional analysis is possible due to post-manufacturing damage.A device history review was unable to be completed as the device is older than 25 years.Prior to august 2014 manufacturing documents for instruments were stored for 10 years.No material review is applicable as the failure is likely related to device age.No hardness review is applicable as the handle material does not have a hardness specification.No definitive root cause could be determined.However, the device handle is composed of phenolic le grade which is susceptible to becoming brittle after repeated thermal cycle such as that which would occur during the sterilization cycle.The device is 25+ years old, per dhr, as such instrument age likely contributed to the complaint condition.Device is an instrument and is not implanted/explanted.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.

Manufacturer Narrative

Date received by manufacture was reported as dec 28, 2017 in (b)(4) in error.The correct date is dec 21, 2017.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.

• Brand Name: SHORTCUT PLATE CUTTER FOR 2.4MM PLATES & THORP
• Type of Device: INSTRUMENT,CUTTING,ORTHOPAEDIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7068657
• MDR Text Key: 93883536
• Report Number: 2939274-2017-50063
• Device Sequence Number: 1
• Product Code: HTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391.967
• Device Lot Number: 1007A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 32 YR