MAUDE Adverse Event Report: SYNTHES TUTTLINGEN UNIVERSAL BENDING PLIERS; PLIERS, SURGICAL

Catalog Number 391.963

Device Problem Break (1069)

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

Event Date 01/07/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient weight is unknown.Device is an instrument and is not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing date: november 7, 2008.Review of the device history records showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.All parts were checked for function at the final inspection.The raw material, which was delivered as lot kr81228, is corresponding to the specifications.No non-conformance reports were generated during production.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.

Event Description

It was reported that a patient underwent a coronary artery bypass on an unknown date.During that procedure, the patient was sutured with non-synthes wires.Postoperatively, the patient experienced a coughing spell.The wires pulled through the sternum causing a sternum fracture.As a result, the patient underwent a sternal reconstruction and chest closure procedure on (b)(6) 2016.The non-synthes wires were successfully removed and the patient was revised to a plate and screw construct.In preparation to implant the plates, the surgeon used the back table to bend the plates.In order to do so, the surgeon used accommodation bending irons to begin plate bending and opted to use smaller universal bending pliers.While bending the plate, the tip of the bending pliers broke off.The surgeon used another set of universal bending pliers, but the same event occurred.The surgeon returned to using of the accommodation bending iron to successfully complete bending of the plates.The surgeon implanted the plates, then tightened and locked the screws into place.The procedure was completed successfully without any reported time delay or further issues.(during the sterilization process, following the procedure, it was discovered that both matrixmandible screwdriver blades, which had been used to tighten the screws, were stripped.Despite the issue, the surgeon had achieved optimal tightening and plate stabilization.Since no fragments were generated, nor were delays caused, these parts will not be included in the reports for this complained event.) this report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (universal bending pliers, part number 391.963, lot number t929157).The subject device was returned with the complaint that the tip of the instrument broke during contouring.The universal bending pliers (391.963) are noted in 11 system technique guides including: titanium sternal fixation, 1.5mm modular lcp, and 2.7mm va locking calcaneal plating.In each instance the device is optional for plate contouring to match patient anatomy.In the sternal fixation system the universal bending pliers are one of two (the other being 329.142) devices intended for contouring.The relevant drawings for the returned instrument were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of this device.A device history review was performed for the returned instrument lot number (as previously reported) and no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.The returned device was examined and the pliers were found to have a broken upper jaw which was not returned.The complaint condition was confirmed.Although a definitive root cause could not be determined, the failure mode is consistent with the application of excessive force.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNIVERSAL BENDING PLIERS
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5385342
• MDR Text Key: 36653835
• Report Number: 9680938-2016-10010
• 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
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391.963
• Device Lot Number: T929157
• Other Device ID Number: (01)10886982198549(10)T929157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2008
• 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
• Patient Age: 82 YR