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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL INSERTION HANDLES; NAIL, FIXATION, BONE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL INSERTION HANDLES; NAIL, FIXATION, BONE Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
510k: this report is for an unknown insertion handle/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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 on an unknown date during intramedullary nailing of left femur, while drilling for proximal transverse locking screw on great troch entry, the surgeon noticed and upon checking the xray the drill was missing anterior to the proximal femoral recon nail.He backed out the drill bit, lifted his hand and the insertion handle and that was enough to correct the angle and drill properly through the nail.There was a surgical delay of 2 minutes.Procedure outcome is successful.Patient status is unknown.Concomitant device reported: unk - powered drivers/handpieces: trauma (part# unknown, lot# unknown, quantity unknown); 11mm / ti cann frn / gt 400mm / left - sterile (part# 04.033.171s, lot# unknown, quantity unknown).This is report 2 of 3 for (b)(4).This report is for an unknown insertion handle.
 
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.Product was not returned.Based on the information: available, it has been determined that no corrective and preventive 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
Update: at this time there is no need to return the aiming arm because the surgeon believes he did not tighten the equipment sufficiently.Per the sales consultant, the equipment was inspected to the best of my ability and everything looks the way it should.There is no product coming back or to be returned.
 
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.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
UNK - NAIL INSERTION HANDLES
Type of Device
NAIL, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key8949548
MDR Text Key195558452
Report Number2939274-2019-60228
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
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 08/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received09/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
11MM / TI CANN FRN / GT 400MM / LEFT - STERILE; UNK - POWERED DRIVERS/HANDPIECES
Patient Weight140
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