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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SOCKET WRENCH FOR VEPTR NUT
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC SOCKET WRENCH FOR VEPTR NUT Back to Search Results
Model Number 03.641.004
Device Problem Failure to Calibrate (2440)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Initial reporter is a synthes employee.Part 03.641.004, lot 6676521: release to warehouse date: september 30, 2011.Supplier: avalign technologies ¿ nemcomed.No non-conformance reports (ncr's) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A service and repair evaluation was completed: during evaluation the repair technician reported the device did not meet calibration.Testing failed is the reason for the repair.The cause of the issue is unknown.The device will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore 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.
 
Event Description
It was reported that on (b)(6) 2019, during evaluation, the repair technician found out that the socket wrench for vertical expandable prosthetic titanium rib (veptr) nut failed in calibration.There was no patient involvement.This report is for a socket wrench.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.
 
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.A product investigation was conducted.Visual inspection: the socket wrench for veptr nut (p/n: 03.641.004, lot # 6676521-01) was returned and received at us cq.Upon visual inspection, there were scratches and the etch on the device started to fade which has no impact on the functionality of the device.No other issues were identified with the returned components of the device.Functional test: the functional test was performed on the returned device at service and repair.The highest torque of the device measured during calibration testing was 7.824 nm which was not within the specified torque range of the device of 5.0 nm - 6.4 nm per ps063839, rev.M.Hence, the torque test failed high.The complaint can be replicated with the returned device.Service & repair evaluation: during service evaluation, the repair technician reported the socket wrench has failed in calibration.The item is not repairable per the inspection sheet.The cause of the issue is the device failed high.The item will be forwarded to customer quality.The finalized service record documenting dispositioning of the device will be archived in the tungsten document management system.The evaluation was confirmed.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint device failed in the calibration test.Document/specification review: based on the date of manufacture the relevant drawings, reflecting the current and manufactured revision were reviewed.The device received failed in calibration testing.Hence, confirming the allegation.Investigation conclusion: the complaint condition is confirmed as the socket wrench for veptr nut (p/n: 03.641.004, lot # 6676521-01) failed high in the calibration test.There is no indication that a design or manufacturing issue has caused the breakage and hence the root cause cannot be determined.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.A device history record (dhr) review was conducted: part # 03.641.002.Synthes lot # 6676521.Supplier lot # 6676521.Release to warehouse date: 30 sep 2011.Supplier: avalign technologies-nemcomed.No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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
SOCKET WRENCH FOR VEPTR NUT
Type of Device
WRENCH
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key8971515
MDR Text Key156896045
Report Number2939274-2019-60378
Device Sequence Number1
Product Code HXC
UDI-Device Identifier10705034720128
UDI-Public(01)10705034720128
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 09/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number03.641.004
Device Catalogue Number03.641.004
Device Lot Number6676521-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2019
Date Manufacturer Received12/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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