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

Model Number	03.221.008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j sales representative.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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) 2020, during an orthopedic procedure of the proximal femur a collinear clamp and an impactor had an unknown allegation along with the two (2) broken cutter.There was no surgical delay.A different set was used.There were no fragments generated and the procedure was completed successfully without patient harm.This report is for one (1) blade for cable cutter this is report 3 of 5 for complaint(b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6- blade for cable cutter (part: 03.221.008, lot: t122513) was returned and received at us cq.Upon visual inspection at cq, it is observed that the device looks good without any visual damage.No defects were identified on device.The complaint cannot be confirmed for blade for cable cutter (part: 03.221.008, lot: t122513) as no visual damage was evident with the returned device.A definitive root cause could not be determined for the reported problem.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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: 03.221.008 lot number: t122513 manufacturing site: tuttlingen release to warehouse date: 12-jan-2016 a review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.Device history batch: null.Device history review : null.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.B5.
Event or Problem Description
This is report 3 of 6 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: 11135306
• Report Number: 2939274-2021-00089
• Device Sequence Number: 13664453
• Product Code: HXZ
• UDI-Device Identifier: 10886982076717
• UDI-Public: 10886982076717
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 12/10/2020

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: T122513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 82