MAUDE Adverse Event Report: UMKIRCH PLATE CUTTER FOR MIDFACE PLATES; INSTRUMENT,CUTTING,ORTHOPAEDIC

Catalog Number 03.503.039

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement reported.Date of event is unknown.Device is an instrument and is not implanted / explanted.Device history records review was completed for part# 03.503.039, lot# 1976572.Manufacturing facility: (b)(4), manufacturing date: sep 16, 2008.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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

During inspection of instrumentation on (b)(6)2016, it was noted that one of the leaf springs was broken on both the plate bender and plate cutter.The leaf spring was found completely broken off and sitting in the tray with the plate cutter.While testing the plate bender, one of the leaf springs snapped off.Both of the broken pieces were placed in the sharps container.There was no patient or surgical involvement.This report is for one (1) plate cutter.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device: 03.503.039 plate cutter for midface plates.A visual inspection under 5x magnification and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned devices are already broken.The plate cutter for midface plates (03.503.039) is noted in four technique guides: curvilinear distractor, matrixcombo plating, cmf distraction, and matrixorthognathic.In each system the cutter is utilized to trim plates to better fit a patient¿s anatomy.The returned instrument is the only cutting instrument in the matrixorthognathic system.The returned instrument was examined and the complaint condition was able to be confirmed as the leaf spring with tab component was found to be broken just distal to where it is secured to the handle with a screw.The broken piece was not returned.No definitive root cause was able to be determined as details as to the method of use at the time of failure were not available; the failure mode is consistent with the application of excessive force/rough handling.Relevant drawings for the returned instrument were reviewed: top-level, spring with tab.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PLATE CUTTER FOR MIDFACE PLATES
• Type of Device: INSTRUMENT,CUTTING,ORTHOPAEDIC
• Manufacturer (Section D): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• Manufacturer (Section G): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6145768
• MDR Text Key: 61469476
• Report Number: 3003862213-2016-10036
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.039
• Device Lot Number: 1976572
• Other Device ID Number: (01)10887587011653(10)1976572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2008
• 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