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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNKNOWN - PLATE CONDYLAR; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNKNOWN - PLATE CONDYLAR; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE Back to Search Results
Device Problem Break (1069)
Patient Problem Bone Fracture(s) (1870)
Event Type  Injury  
Manufacturer Narrative
This report is for an unk - plate condylar/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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.
 
Event Description
It was reported on (b)(6) 2020, that the patient underwent revision of a variable angle (va) condylar plate, due to two (2) screws have backed out and the fracture may have become a nonunion or malunion as seen in the x-ray.Not all implanted devices were explanted.Broken fragment of a locking screw.It is possible that the lag screws remained.The procedure was completed successfully with no surgical delay.The patient status is good.Concomitant devices reported: unknown screws (part# unknown, lot# unknown, quantity# 11).This is report 04 of 04 of (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.The received x-ray was reviewed and the reported screw back out can be confirmed for two screws.Therefore is the complaint rated as confirmed regarding the back out.Product was not returned and no article- and lot number was provided, therefore no further evaluation is possible.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
Updated event: revision surgery occurred (b)(6) 2020.One screw broke intraoperatively during the revision and created a fragment.The screws that backed out were removed.(b)(4) captures the screws that backed out postoperatively and (b)(4) captures the locking screw that broke upon removal intraoperatively.
 
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.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
UNKNOWN - PLATE CONDYLAR
Type of Device
IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key9666866
MDR Text Key190318072
Report Number2939274-2020-00633
Device Sequence Number1
Product Code JDP
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 01/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2020
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 Received02/28/2020
Patient Sequence Number1
Treatment
UNK - SCREWS: TRAUMA
Patient Outcome(s) Required Intervention;
Patient Age80 YR
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