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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES; PLATE,FIXATION,BONE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES; PLATE,FIXATION,BONE Back to Search Results
Device Problem Break (1069)
Patient Problem Reaction (2414)
Event Date 05/07/2020
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown plate/ 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.Reporter is a j&j employee.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 (b)(6) 2020, the case involved fixation of a mandible fracture were plate and screws removed and the surgeon noticed a small portion of plate facing bone had flaked off.The surgeon selected cut to an unknown 2.4 modular mandible plate but unclear if the part number were 449.612 or 449.621 due to the piece selected not having a reference number on it on an unknown date.Previously cut plate was bent to conform and screws were placed and the surgeon was not happy with fixation.It is unclear which of 3 screws were used in this hole.The surgeon selected a new plate and successfully implanted it with appropriate screws.The procedure successfully completed.The patient outcome is unknown.Concomitant device reported: unk - screws: trauma (part # unknown, lot # unknown, quantity # 2), 2.4mm titanium cortex screw self-tapping 10mm (part # 405.510, lot # unknown, quantity # 1).This complaint involves one (1) device.This report is for one (1) unk - plates.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.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 is report 1 of 2 for (b)(4).
 
Event Description
Updated event description: it was reported that on (b)(6) 2020, the patient underwent an revision surgery to treat the mandible fracture with plate and screws.For the fixation, surgeon selected previously cut (unsure of date when it was cut) 2.4 modular mandible plate.Previously cut plate was bent to conform and screws were placed and the surgeon was not happy with fixation.Plate and 3 screws were removed and surgeon noticed that a small portion of plate facing bone had flaked off.It is unclear which of 3 screws were used in that hole.The surgeon selected a new plate and successfully implanted it with appropriate screws.The procedure successfully completed.The patient outcome is unknown.Concomitant device reported: unk - screws: trauma (part # unknown, lot # unknown, quantity # 2); 2.4mm titanium cortex screw self-tapping 10mm (part # 405.510, lot # unknown, quantity # 1).This report is for one (1) unknown plate.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.The device has been 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.H10 additional narrative: investigation summary: flow damage.Visual inspection: the device was found to be bent/deformed and broken at 6th hole.Hence the complaint can be confirmed.The broken piece(etched side) was not returned.Since we can not identified the plate's full length and cannot find out the total number holes the plate had, it is not possible to tell the received plate part number is 449.612 or 449.621.Dimensional inspection: it was not performed due to clear evidence of post manufacturing damage.Document/specification review: mre could not be performed since the lot number is unknown.Conclusion: 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 the device encountered unintended forces.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.
 
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
Updated event: it was reported that on (b)(6) 2020, the case involved fixation of a mandible fracture were plate and screws removed and the surgeon noticed a small portion of plate facing bone had flaked off.The surgeon selected cut to an unknown 2.4 modular mandible plate but unclear if the part number were 449.612 or 449.621 due to the piece selected not having a reference number on it on an unknown date.Previously cut plate was bent to conform and screws were placed and the surgeon was not happy with fixation.It is unclear which of 3 screws were used in this hole.The surgeon selected a new plate and successfully implanted it with appropriate screws.The procedure successfully completed.The patient outcome is unknown.Concomitant device reported: 2.4mm ti locking screw 12mm f/locking reconstruction plate (part # 497.672 , lot # unknown, quantity # 1).2.4mm titanium cortex screw self-tapping 10mm (part # 405.510, lot # unknown, quantity # 1).
 
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Brand Name
UNK - PLATES
Type of Device
PLATE,FIXATION,BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key10080789
MDR Text Key191808787
Report Number2939274-2020-02482
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2020
Date Manufacturer Received07/05/2020
Patient Sequence Number1
Treatment
2.4MM TI CORTEX SCREW SELF-TAPPING 10MM; 2.4MM TI CORTEX SCREW SELF-TAPPING 10MM; 2.4MM TI LOCKING SCREW 12MM F/LOCKING RECON PL; UNK - SCREWS: TRAUMA
Patient Outcome(s) Required Intervention;
Patient Age44 YR
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