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

Model Number	391.93
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement was reported.Date of device breakage is not known.Device is an instrument and is not implanted/explanted.Initial reporter is synthes sales consultant dhr review: part no.: 391.930, lot no.: 8812.Dhr not available as device is older than 39 years.At this time the manufacturing documents for instruments had to be stored for 10 years.This was according to filing and archiving of specification documents, which was in place till august 2014.Customer quality conducted an investigation of the returned device.Service & repair evaluation: the customer reported the wire cutter was pitted.The repair technician reported the cutting jaws were chipped in three places, and a piece was 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.This complaint was able to be confirmed via visual inspection at customer quality (cq).The cutting jaws are chipped in three places and a piece is missing.Whether this complaint can be replicated at cq via functional test is not applicable for this complaint condition.Drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.A drawing from time of manufacture could not be found due to age of the device.The 391.93(0) wire cutter is an instrument routinely used in the cannulated percutaneous guiding system to cut k-wires.The returned device has "made in (b)(6) 881" etched on it.Therefore, it is most likely that it was manufactured by a supplier in (b)(4) for synthes.A material check or hardness check were not performed at cq as there is no indication that the material or hardness would have contributed to this complaint for this old reusable instrument breaking.A dimensional inspection of features relevant to this complaint could not be obtained at cq due to post manufacturing damage.Although a definitive root cause could not be determined, this complaint condition is likely due to consistent use and rough handling over the part's lifetime causing the wire cutter jaws/edges to break.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 or Problem Description
It was reported that the wire cutter 220mm is pitted.This issue was discovered upon routing examination.No hospital or patient involvement.Evaluation of the returned device revealed the cutting jaws were chipped in three (3) places and a piece was broken off.This report is for one (1) 220mm wire cutter this is report 1 of 1 for (b)(4).

• Brand Name: WIRE CUTTER 220MM
• Common Device Name: CUTTER,WIRE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7486551
• Report Number: 2939274-2018-52010
• Device Sequence Number: 13944047
• Product Code: HXZ
• UDI-Device Identifier: 10886982198440
• UDI-Public: (01)10886982198440
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2018

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
• Operator of Device: Health Professional
• Device Model Number: 391.93
• Device Catalogue Number: 391.93
• Device Lot Number: 8812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Initial Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1