MAUDE Adverse Event Report: SYNTHES TUTTLINGEN WIRE CUTTER 220MM; CUTTER, WIRE

Catalog Number 391.93

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred during a veterinary case.As such, no patient identifiers will be reported.The manufacturer was originally made aware of an issue with this device on (b)(6) 2016.The known information at the time did not represent a reportable incident.On (b)(6) 2016, however, additional information referencing a fragment was received.The event was re-assessed and determined to be reportable.Device is an instrument and is not implanted or explanted.(b)(6).Service & repair evaluation: the customer reported the blade chipped while cutting; the repair technician reported the cutting jaws were chipped and broken.Cutting jaws broken is the reason for repair; however, the item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded for further evaluation.Service history record review: no service history review could be performed as part: 391.93 / lot: t119254 is a lot/batch controlled item.The manufacture date of this item is october 14, 2015.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.A review of the device history records will be requested based upon provided part and lot numbers for the complainant device.Upon completion, details will be provided.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 the blade of a wire cutter chipped during an open reduction internal fixation (orif) procedure of a right ulna fracture on (b)(6) 2016.The chipping/breakage occurred as the surgeon was using the device to cut a 3/32nd pin.The missing piece was recovered from the table prior to the completion of the procedure.A competitor¿s device was readily available for usage.The procedure concluded with a noted two (2) minute delay.The patient was said to be making ¿appropriate progress¿ for the short post-operative time period.Concomitant device(s) reported: 3/32nd pin (part/lot: unknown / quantity: 1).This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A manufacturing investigation including a device history record review were completed for the complaint device (wire cutter 220mm, part number 391.93, lot number t119254).The device was received in very good condition with the tip broken 5mm at the tip.Three cutting tests were performed which included the tip, the middle, and the end of the cutting jaws.These tests were performed during the final inspection of the device after manufacture using a 2mm wire on oct 8, 2015.All three tests were conforming.An additional test was performed during the manufacturing investigation with a similar 2mm wire at the middle and at the end of the jaws and found to be good.The associated product drawings were also reviewed.A device history record review was performed for the complaint device lot.The device lot was manufactured in synthes tuttlingen.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 complaint device.A review of inspection records and certifications, confirm that the, material, components and final product met inspection records, certification.All 32 parts of the lot were checked 100% for ctq features and for the cutting function at three different positions at the final inspection on (b)(4) 2015.The manufacturing date of this lot is oct 9, 2015.The complaint condition is confirmed although no manufacturing issues were found during the investigation.A root cause could not be determined based on the reported event description the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A product investigation was completed: a visual inspection, device history record (dhr) review, manufacturing investigation, complaint history review and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The device was returned and reported to be broken.This condition is confirmed.The relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.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.Per the technique guide, the 391.93 wire cutter is an instrument routinely used in the cannulated percutaneous guiding system.Unable to determine a definitive root cause.However, the complaint condition was most likely caused by application of excessive force.It is not likely that the design of the device contributed to this complaint.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: WIRE CUTTER 220MM
• Type of Device: CUTTER, WIRE
• 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: 5791775
• MDR Text Key: 49456242
• Report Number: 9680938-2016-10098
• Device Sequence Number: 1
• Product Code: HXZ
• 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,Followup
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391.93
• Device Lot Number: T119254
• Other Device ID Number: (01)10886982198440(10)T119254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/05/2016; 08/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2015
• 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