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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED SCREW MEASURING DEVICE FOR 3.5MM & 4.0MM; SCREW, FIXATION, BONE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED SCREW MEASURING DEVICE FOR 3.5MM & 4.0MM; SCREW, FIXATION, BONE Back to Search Results
Catalog Number 319.15
Device Problems Fitting Problem (2183); Device-Device Incompatibility (2919)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Patient information is not available for reporting.This report is for an unknown - screw: 4.0 mm cannulate /unknown lot.Part and lot numbers are unknown; udi number is unknown.Not implanted or explanted, a different size screw was used.Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.
 
Event Description
It was reported that on an unknown date, during an unknown procedure, a depth gauge that works in conjunction with the k-wire did not measure correctly when the surgeon was trying to measure a 4.0 mm cannulated screw.There was a surgical delay for almost 20 minutes or so, in an attempt to take out the screw and put in a different size screw.The issue did not impact the patient.Concomitant devices reported: unknown k-wires (part # unknown, lot # unknown, quantity 1), unknown 4.0 mm cannulated screw (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
 
Event Description
It was further reported, the procedure was completed on schedule.There was no back-up device.They just continued with the procedure.The patient outcome is unknown.
 
Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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
This report is for one (1) unknown 4.0mm cannulated screw.
 
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.This report is for one (1) unknown 4.0mm cannulated screw/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not returned for manufacturer review/investigation.Without specific part and lot number, the physical manufacturer is unknown.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.
 
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 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.Event : unknown 4.0 mm cannulated screw (part # unknown, lot # unknown, quantity unknown) is no longer considered concomitant.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
CANNULATED SCREW MEASURING DEVICE FOR 3.5MM & 4.0MM
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key7931060
MDR Text Key122639827
Report Number2939274-2018-54126
Device Sequence Number1
Product Code HWC
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
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number319.15
Device Lot NumberA4DE172
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2018
Date Manufacturer Received11/07/2018
Patient Sequence Number1
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