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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW INSERTER; ROD,FIXATION,INTRAMEDULLARY
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW INSERTER; ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 03.037.025
Device Problems Use of Device Problem (1670); Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.Device was used for treatment, not diagnosis.
 
Event Description
It was reported on (b)(6) 2018, during a resident in service, while the sales consultant was putting the screw inserter into an unknown insertion handle, something was bent.The devices were not connecting easily.There was no patient involvement.This complaint involves two (2) devices.This report is 1 of 2 for (b)(4).
 
Manufacturer Narrative
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.Additional narrative: event, concomitant medical products.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
Concomitant devices: lag screw (part: unknown, lot: unknown, quantity: 1).
 
Event Description
It was reported on (b)(6) 2018, during a resident in service, while the sales consultant was putting the helical blade/screw coupling screw into an screw inserter, something was bent.The devices were not connecting easily.There was no patient involvement.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.H3, h4, h6: device history records review was completed for part: 03.037.025, lot: 9850516.Manufacturing location: bettlach, release to warehouse date: mar 16, 2016.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.H3, h6: product investigation was completed.Visual inspection confirmed that there were no damage to the screw inserter handle.It was determined that the received condition does not agree with the complaint description and is not confirmed as no damage were observed on the returned device.A functional test was performed by assembling the screw inserter with the returned mating coupling screw.The devices were found to assemble and disassemble as intended with no noted issues.Relevant drawings were reviewed during this investigation.A relevant dimensional inspection was performed.The distal end of screw inserter handle had internal diameter of 6.11 mm and dimensional inspections were completed with gauge pins gp32.This is within the specification of 6.15 +/- 0.04 mm per drawing.The complaint condition is unconfirmed as no bending or damage were observed on the returned device.No malfunctions were observed during the course of this investigation.As such, no design or manufacturing defect or deficiency was identified.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.E3: reporter is synthes sales consultant.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
SCREW INSERTER
Type of Device
ROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key8122590
MDR Text Key129039383
Report Number2939274-2018-55228
Device Sequence Number1
Product Code HSB
UDI-Device Identifier10886982070418
UDI-Public(01)10886982070418
Combination Product (y/n)N
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup,Followup
Report Date 11/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number03.037.025
Device Catalogue Number03.037.025
Device Lot Number9850516
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2018
Date Manufacturer Received01/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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