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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 200MM; APPLIANCES,FIXATION,NAIL/BLD/PL COMBO,MULTI COMP, METAL COM
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 200MM; APPLIANCES,FIXATION,NAIL/BLD/PL COMBO,MULTI COMP, METAL COM Back to Search Results
Model Number 294.56
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.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 an unknown date, the depth gauge 2.0/2.4mm depth probe tip snapped off.The schantz screw 5.0mm trocar point stuck inside holding sleeve.And the holding sleeve tightening key broke off, unable to remove schantz screw inside.No other details have been provided.This report is for one (1) 5.0mm schanz screw blunted trocar point 200mm.This is report 2 of 3 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.H3, h6: the device was 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: the 5.0mm schanz screw blunted trocar point 200mm (p/n: 294.56, lot #: 3002455) was returned and received at us cq.Upon visual inspection it was observed that the broken tip of the mating device (wing screw) was retained in the threaded portion of the holding sleeve when assembled with the 5.0 mm schanz blunted trocar point 200 mm not allowing the device to disassemble.The device shows only light surface wear consistent with use and which would not impact the functionality.No, the received condition does not agree with the complaint description and is not confirmed as no fractures/breaks were observed on the returned device.The mating device was noted to be broken.Conclusion: the complaint condition is unconfirmed as no damage were observed on the5.0mm schanz screw blunted trocar point 200mm (p/n: 294.56, lot #: 3002455).There is no indication that a design or manufacturing issue was identified.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: a dhr review was not performed for this pi.This lot was manufactured by elmira.Please reassign to the correct group.Part number: 294.56.Lot number: 3002455.Part manufacture date: 28-jul-1998.Manufacturing location: monument.Part expiration date: n/a.Nonconformance noted: n/a.Dhr record review: lot 3002455 of 5.0mm schanz screw blunted trocar point 200mm product was manufactured in monument prior to the existence of the elmira manufacturing facility.The product line is currently manufactured in the elmira manufacturing facility.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 5.0mm schanz screw blunted trocar point 200mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.H11 corrected data: g3.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
5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 200MM
Type of Device
APPLIANCES,FIXATION,NAIL/BLD/PL COMBO,MULTI COMP, METAL COM
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key9557803
MDR Text Key193597049
Report Number2939274-2020-00069
Device Sequence Number1
Product Code LXT
UDI-Device Identifier10886982181572
UDI-Public(01)10886982181572
Combination Product (y/n)N
PMA/PMN Number
K161417
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number294.56
Device Catalogue Number294.56
Device Lot Number3002455
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2020
Initial Date Manufacturer Received 12/12/2019
Initial Date FDA Received01/07/2020
Supplement Dates Manufacturer Received01/22/2020
02/05/2020
Supplement Dates FDA Received01/31/2020
02/10/2020
Patient Sequence Number1
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