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

Catalog Number 03.503.039

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Event date: unknown.Implant and explant dates: 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 subject device was received.The investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 plate cutter for midface plates is broken and is not cutting plates.The issue was discovered in the central sterile department during preparation for an upcoming surgery.It is unknown when the plate cutter was broken.There was no patient or surgical involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the complaint condition for the plate cutter was likely caused by the application of excessive mechanical overload on the instrument.Per the technique guide, the plate cutter can be utilized in the matrixorthognathic system.The instrument is one of three to customize system plates to a patients¿ anatomy and the only plate cutter in the system.Upon visual inspection of the complaint device it can be seen that the leaf spring was found to be broken.A definitive root cause was unable to be determined however the complaint condition is consistent with the application of excessive force on a multiuse instrument over 5+ years in the field.This complaint is confirmed.The relevant drawings were reviewed.The design history was found to not impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.Device history record reviewed.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The complaint condition for the plate cutter was likely caused by the application of excessive mechanical overload on the instrument.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5396011
• MDR Text Key: 36981215
• Report Number: 3003862213-2016-10002
• 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,Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• 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: 3453890
• Other Device ID Number: (01)10887587011653(10)3453890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2010
• 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