MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BLADE FOR CABLE CUTTER; CUTTER, WIRE

Model Number	03.221.008
Medical Device Problem Codes	Failure to Cut (2587); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative:: reporter is a j&j sales representative.A product investigation was conducted.Visual inspection: the blade for cable cutter (p/n: 03.221.008, lot #: t162927) was returned and received at us cq.Upon visual inspection the proximal threads on the inner blade are observed to be deformed.No other issues were observed with the returned device.Functional test: a functional test cannot be performed as the device was returned by itself.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed investigation conclusion: the complaint condition was not confirmed for the blade for cable cutter (p/n: 03.221.008, lot #: t162927).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the deformed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A device history record (dhr) review was conducted: part number: 03.221.006 lot number: t162927 manufacturing site: (b)(4).Release to warehouse date: (b)(6) 2018.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.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 on (b)(6) 2021, during total hip replacement, the cable cutter stop cutting, get stuck and will not cut cables.Procedure outcome and patient status are unknown.During manufacturer's investigation of the returned device it was identified that the proximal threads on the inner blade are deformed.This device condition was determined to be reportable on (b)(6) 2021.This report is for one (1) blade for cable cutter this is report 1 of 1 for complaint (b)(4).

• Brand Name: BLADE FOR CABLE CUTTER
• 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: 12053840
• Report Number: 2939274-2021-03187
• Device Sequence Number: 4421800
• Product Code: HXZ
• UDI-Device Identifier: 10886982076717
• UDI-Public: (01)10886982076717
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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: 03.221.008
• Device Catalogue Number: 03.221.008
• Device Lot Number: T162927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1