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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; WASHER, BOLT NUT
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC; WASHER, BOLT NUT Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Foreign Body In Patient (2687); No Code Available (3191)
Event Date 12/28/2018
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This report is for (2) unknown washers/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.
 
Event Description
It was reported that on (b)(6) 2018, a removal of 6.5/7.3 cannulated screws was performed on the pelvis due to pain.During the procedure, the first three (3) screws came out without issues, however one of the pubic symphysis screws was difficult to remove with what seemed like bony or soft tissue over growth and lack of screw purchase in bone.The surgeon open the pubic symphysis area to retrieve the screw.All screws were retrieved intact.Two (2) 13mm washers remained in the patient.There was no infection noticed however it seemed that some of the reduction had been lost.It is unknown if there was surgical delay.Procedure outcome and patient status is unknown.This complaint involves two (2) devices.This report is for two (2) unk - washers.This report is 1 of 2 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.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.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.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 captures the intra op event which involves difficulty in removing the screw while related complaint (b)(4) captures the post op event which involves a removal of screws due to pain.
 
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Type of Device
WASHER, BOLT NUT
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key8263792
MDR Text Key133706156
Report Number2939274-2019-55969
Device Sequence Number1
Product Code HTN
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,Followup
Report Date 12/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received02/26/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age37 YR
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