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

Model Number	03.607.513
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cable cutter (p/n: 03.607.513, lot number: l874573) was received at us cq.Visual inspection of the complaint device showed a piece had broken off on the jaw tip.This complaint is confirmed as the jaw tip has a piece broken off.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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.Device history lot.Part number: 03.607.513.Lot number: l874573.Manufacturing site: (b)(4).Release to warehouse date: 22.May 2018 a manufacturing record evaluation 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 unknown date, the cable cutter were found in set to be broken.This was discovered when they opened the set for the case.There was no patient involvement.This report is for one (1) cable cutter.This is report 2 of 2 for (b)(4).

• Brand Name: 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: 11516016
• Report Number: 2939274-2021-01393
• Device Sequence Number: 3412427
• Product Code: HXZ
• UDI-Device Identifier: 10886982080585
• UDI-Public: (01)10886982080585
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 02/21/2021

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: 03.607.513
• Device Catalogue Number: 03.607.513
• Device Lot Number: L874573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2021
• Initial Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1