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

Model Number 03.221.008

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2020

Event Type  malfunction  

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 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).

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 Description

This is report 3 of 6 for complaint (b)(4).

• Brand Name: BLADE FOR CABLE CUTTER
• Type of Device: CUTTER,WIRE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11135306
• MDR Text Key: 225993361
• Report Number: 2939274-2021-00089
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10886982076717
• UDI-Public: 10886982076717
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 82