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

Model Number 03.221.006

Device Problem Failure to Cut (2587)

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

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: part number: 03.221.006.Lot number: t162927.Manufacturing site: (b)(4).Release to warehouse date: november 9, 2018.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the cable cutter w/trigger handle (part #: 03.221.006, lot #: t162927) was received at us customer quality (cq).Visual inspection of the complaint device showed that the nose piece of the device, the cutter was not returned.Only the trigger was returned.There was only foreign material apparently a spot of glue on the trigger.No other defect was observed functional test: a functional assessment was not performed with the complaint device since the applicable mating components (the cutter and the cable) were not returned.Can the complaint be replicated with the returned device? unable to perform dimensional inspection: no dimensional inspection was performed due to requiring destruction of the device, and device assembly and geometry limits ability to accurately dimensionally inspect document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: the overall complaint is confirmed as the complaint device was returned missing its nose piece (cutter).However, the reported allegation could not be confirmed as functional assessment was not able to be performed due to missing cable and the nose piece.Only the trigger was returned.The foreign material observed did not contribute in anyway to the complaint condition.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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) 2021, during a total hip replacement surgery the cable gun would not cut cable.The trigger would not work.Another cutter was used for the procedure.The procedure was completed successfully without surgical delay.There was no patient consequence.This report involves one (1) cable cutter w/trigger handle.This is report 1 of 1 for (b)(4).

• Brand Name: CABLE CUTTER W/TRIGGER HANDLE
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12415366
• MDR Text Key: 271125564
• Report Number: 2939274-2021-05142
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10886982076694
• UDI-Public: (01)10886982076694
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.221.006
• Device Catalogue Number: 03.221.006
• Device Lot Number: T162927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR