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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TRIGGER HANDLE F/CABLE CUTTER; CUTTER,WIRE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TRIGGER HANDLE F/CABLE CUTTER; CUTTER,WIRE Back to Search Results
Catalog Number 03.221.007
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 an unknown date, during routine maintenance, the trigger handle f/cable cutter was found broken.There was no patient involvement.This report is for one (1) trigger handle f/cable cutter.This is report 1 of 1 for (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: d4, h4: additional information provided.H3, h6: the device was 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.
 
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.Part: 03.221.007; synthes lot: t934058; release to warehouse date: april 17, 2009; manufacture site: tuttlingen; part expiration date: n/a.Further review of the device history records (dhr) showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition.The raw material certificate was reviewed, and the used material was according to the specification of the device.Review of the device history record of tuttlingen showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.Background: the cable cutter (03.221.006) is part of the orthopedic cable system.Once the wire is tensioned, the cutter is used to trim the wire close to the crimp without fraying the cable.The 03.221.007 trigger handle is one of two (2) instruments of the 03.221.006 cable cutter assembly.The other instrument is the 03.221.008 cable cutter.Visual inspection: the trigger handle f/ cable cutter was received at us cq with the trigger separated from the cable cutter.The two pieces of the assembly were put together easily.During the investigation at us cq, the pusher was discovered missing.This is not consistent with the reported complaint condition.Therefore, the complaint is not confirmed.Dimensional inspection: dimensional analysis was not performed as relevant parts/features were not returned.Document/specification review: the following drawings were reviewed: cable cutter handle with trigger.Trigger.Pusher.Conclusion: the complaint condition is not confirmed as the trigger handle f/ cable cutter was received with the trigger missing a pusher and not broken.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined, it is possible that during processing and sterilization that the pusher was lost.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.
 
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Brand Name
TRIGGER HANDLE F/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 Key8326402
MDR Text Key136908344
Report Number2939274-2019-56393
Device Sequence Number1
Product Code HXZ
UDI-Device Identifier10886982076700
UDI-Public(01)10886982076700
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 01/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.221.007
Device Lot NumberT934058
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2019
Date Manufacturer Received03/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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