MAUDE Adverse Event Report: SYNTHES TUTTLINGEN MATRIXMANDIBLE COMBINATION BENDER; PLIERS, SURGICAL

Catalog Number 03.503.056

Device Problem Break (1069)

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

Event Date 05/13/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 a matrixmandible combination bender broke during surgery.On (b)(6) 2016 a patient underwent an initial open reduction internal fixation of a mandibular fracture.The surgeon used a combination bender out of a matrixmandible set to bend a plate, and the bender broke.The case went on without interruption.There was no surgical delay.The patient did not suffer any ill effects and the procedure was successfully completed.The patient outcome was stable.This complaint involves one device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A device history record review was performed for the subject device lot number t934907.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 has been received and is currently in the evaluation process.Device manufacture date.Corrected data: lot number and udi.Street address.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Clarification: patient identifier and weight are unknown.Product investigation summary: one (1) matrixmandible combination bender (part: 03.503.056 / lot: t934907) was received for evaluation with the complaint category "broken: intraoperatively." this complaint is confirmed as the returned device was received in two (2) pieces (portion of the leaf spring component is sheared off and is separate from remainder of bending instrument).The leaf spring sheared off approximately 25mm from the location where it is secured to the handle with a screw.The sheared off section of the leaf spring is approximately 50mm in length.A visual inspection, device history record (dhr) review, and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The manufacturer is unable to determine a definitive root cause.However, the complaint condition was most likely caused by excessive force.It is not likely that the design of the instrument contributed to this complaint.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.A review of the product drawing was conducted during this evaluation.No product design issues or discrepancies were observed.Device 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 COMBINATION BENDER
• Type of Device: PLIERS, SURGICAL
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5686344
• MDR Text Key: 46167516
• Report Number: 2520274-2016-12915
• Device Sequence Number: 1
• Product Code: HTC
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.056
• Device Lot Number: T934907
• Other Device ID Number: (01)10887587011776(10)T934907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2009
• 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: 16 YR