MAUDE Adverse Event Report: SYNTHES TUTTLINGEN MATRIXMANDIBLE PLATE BENDING PLIERS-LEFT; INSTR,BENDING OR CONTOURING

Catalog Number 03.503.041

Device Problem Break (1069)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information is unknown.Date of event is unknown.Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot number t944992.Manufacturing location: (b)(4).Date of manufacture: 01-apr-2010.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 device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 while performing a routine inspection of the set, it was noticed that there is a little chip missing out of one of the teeth in the matrixmandible plate bending pliers, left.No patient involvement.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product development investigation was performed.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.This complaint is confirmed.A corner of the distal ledge that aligns plates has sheared off of one of the jaws.The sheared off fragment was not returned.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.No new malfunctions were identified as a result of the investigation.The returned matrixmandible plate bending pliers-left are a reusable instrument in the matrix mandible plating system used to aid in contouring plates to fit patient anatomy.Relevant drawing was reviewed during this investigation.No product design issues or discrepancies were observed.Unable to determine a definitive root cause.It is most likely the result of cumulative wear for this 7 year old reusable bending plier.No new, unique or different patient harms were identified as a result of this evaluation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.There was no known reported patient involvement associated with the complained event.(b)(4).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: MATRIXMANDIBLE PLATE BENDING PLIERS-LEFT
• Type of Device: INSTR,BENDING OR CONTOURING
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6515224
• MDR Text Key: 73458161
• Report Number: 9680938-2017-10068
• Device Sequence Number: 1
• Product Code: HXP
• UDI-Device Identifier: 10887587011677
• UDI-Public: (01)10887587011677(10)T944992
• 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: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.041
• Device Lot Number: T944992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2010
• 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