MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC WIRE CUTTER 220MM; CUTTER, WIRE

Model Number 391.93

Device Problems Dull, Blunt (2407); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Device used in a veterinary case - no patient information will be reported.Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed for part number: 391.93, synthes lot number: 4622484, synthes lot number: 4622485, supplier lot number: a7ma27, release to warehouse date: 17jul2003: supplier: (b)(4): no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.A product investigation was conducted.The wire cutter (part: 391.93, lot: a7ma27, mfg: 17-jul-2003) was received with the reported conditions will not close/open and missing conditions: nrm.The device was initially received at service and repair.The customer reported the cutter would not close, and a component was missing.The repair technician reported the jaws were chipped and missing.Cutting jaws broken is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.At customer quality, the returned wire cutter part: 391.93, lot: a7ma27, mfg: 17-jul-2003) was inspected and no missing components were observed.The returned device was able to be opened/closed and therefore the reported complaint conditions were unable to be confirmed.However, the cutting edges of the device was observed to be worn and chipped.Therefore, the overall complaint condition was confirmed.The following investigations were performed: broken: visual inspection performed at customer quality observed that the cutting edges on both the handles were significantly worn and chipped.The cutting edges were observed to have incomplete contact with each other, when the handles of the given device were compressed because of the missing broken fragments.Broken fragments were not returned at customer quality.No sign of damage was observed on the remaining portions of the device.The received condition does not agree with the complaint description.However new issues (chipped and worn conditions) were identified.Therefore, the overall complaint condition was confirmed.Relevant drawings for the returned device (both current and from the time of manufacture): top-level assembly drawing for wire cutter were reviewed.Both dimensional analysis and a material check or hardness check were not performed at cq as there is no indication that the material or hardness and device specifications would have contributed to the complaint condition for this 14+ year old reusable instrument.Additionally, and device shows post manufacturing damage such that a relevant dimensional check could not be performed.While no definitive root cause could be determined, it is likely that over 14 years of consistent use and any unintended forces encountered by the device during usage/ handling could have led to damaged cutting-edge complaint condition.Also, based on the visual inspection, it is possible that the broken portions of the cutting edges leading to incomplete contact of two cutting edges in closed position, could have contributed to will not close complaint condition.During the investigation, no product design or manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 during a procedure that was performed on dog, as the surgeon was cutting a pin implant, the wire cutter instrument would not close.It was noted that a necessary component piece on the instrument was missing.No additional time was added due to this event.Surgery was completed successfully with another like instrument.During manufacturer¿s investigation of the returned device it was identified that the cutting edges of the device are worn and chipped.This condition was re-evaluated and determined to be reportable on june 1, 2018.Concomitant device reported: unknown pin (part # unknown, lot # unknown, quantity 1).This is report 1 of 1 for complaint (b)(4).

• Brand Name: WIRE CUTTER 220MM
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7562601
• MDR Text Key: 110476659
• Report Number: 2939274-2018-52390
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10886982198440
• UDI-Public: (01)10886982198440
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/02/2018

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 Model Number: 391.93
• Device Catalogue Number: 391.93
• Device Lot Number: A7MA27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2003
• 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