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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE WITH MINI QUICK COUPLING; TAP, BONE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE WITH MINI QUICK COUPLING; TAP, BONE Back to Search Results
Model Number 311.01
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.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 on an unknown date, it was found out during hospital inventory that the screwdriver handle with mini quick coupling broke off.There was no patient or procedure involvement.This report is for one (1) handle with mini quick coupling.This is report 1 of 1 for complaint (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 evaluated by mfr: dhr review was completed.Part # 311.01 synthes lot # 4941899 supplier lot # na release to warehouse date: 04feb2005.Manufactured by synthes brandywine.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Material record review was generated during production for non-conformance, correct specification.The product was dispositioned as use as is.This non-conformance is not relevant to the complaint since 25jan2004.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.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.Part: 311.01; synthes lot: 4941899; supplier lot: na; release to warehouse date: february 04, 2005; manufactured by synthes brandywine the raw material was confirmed to be correct per the specification with no relevant non-conformance noted.Manufacturer review report (mrr) was generated during production for nonconformance u/s to 10.165, correct specification 10.21 / 10.18.The product was dispositioned as use as-is.While this non-conformance for undersized handle dimensions is related to the complaint condition of handle breaking, it is determined that this non-conformance from 2005 for 0.015mm undersized diameter had minimal relation to the handle breaking thirteen (13) years after manufacture.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device evaluation: investigation flow: broken.Visual inspection: the device was returned to service and repair.The repair technician reported the handle was broken with two loose pieces.The handle was deemed unrepairable per the inspection sheet and forwarded to us customer quality for further investigation.Upon receipt, the service evaluation was able to be confirmed as the device¿s phenolic handle was found to be broken around the asif mark close to the narrow bend region.Also, another crack was noticed on the phenolic handle that was still attached to the device.The complaint condition was unable to be replicated due to post-manufacturing damage.The returned condition is consistent with extensive wear and repeated sterilization of the device over an extended lifetime.The handle material is phenolic le grade which is susceptible to becoming brittle after being subjected to years of thermal cycling which routinely occurs during sterilization cycles.The device is 13+ years old (manufactured in march 2005), therefore the device age is likely a contributing factor.This is consistent with the reported complaint condition, thus confirming the complaint.Document review: the following relevant drawings, reflecting the current revision and the manufactured revision of the device (top level) and the handle (sub-component), were reviewed: handle with mini quick coupling - current version.Handle with mini quick coupling - version at the time of manufacture of the returned device.Handle maxillofacial.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The raw material was confirmed to be correct per the specification with no relevant non-conformance noted.Review of the device history record(s) of the handle sub component showed that an mrr was generated during production for non-conformance.The diameter of distal end of the shaft (within the handle sub-component) measured u/s to 10.165 which didn¿t meet the correct specification of 10.21 / 10.18.The product was dispositioned as use as-is.While this non-conformance for undersized handle dimensions is related to the complaint condition of handle breaking, it is determined that this non-conformance from 2005 for 0.015mm undersized diameter had minimal relation to the handle breaking thirteen (13) years after manufacture.The design, materials, and finishing processes were found to be appropriate for the intended use of this device.No dimensional analysis is possible due to post-manufacturing damage.Conclusion: the complaint condition is confirmed as the device was received broken.No service history review was possible as the device is lot/batch controlled.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 underwent extensive wear and repeated sterilization over an extended lifetime.No new malfunctions were observed during this investigation.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.
 
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Brand Name
HANDLE WITH MINI QUICK COUPLING
Type of Device
TAP, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key7954416
MDR Text Key123399142
Report Number2939274-2018-54300
Device Sequence Number1
Product Code HWX
UDI-Device Identifier10886982187192
UDI-Public(01)10886982187192
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,health
Type of Report Initial,Followup,Followup
Report Date 09/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number311.01
Device Catalogue Number311.01
Device Lot Number4941899
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2018
Date Manufacturer Received11/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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