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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 Device-Device Incompatibility (2919)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
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, as no product was received.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 on august 4, 2019, the sales consultant was examining the locking mini fragment set and noticed that the handle with mini quick coupling was not holding the screwdriver shaft.There was no patient involvement.Concomitant device reported: unk - screwdrivers: shafts: trauma (part # unknown, lot # unknown, quantity 1).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.A product investigation was conducted.Visual inspection: handle with mini quick coupling (qty:1, part#311.01, lot#a4gq656) was received at cq.Visual inspection of the returned handle with mini quick coupling performed at customer quality (cq) that the locking sleeve of the coupling insert was found to be slightly loosened.Additionally, a minor gap has been observed between the shaft and the handle portion.Therefore, the complaint condition was confirmed.Service & repair evaluation: the customer reported the handle with mini quick coupling was not holding the screwdriver shaft.The repair technician reported the part will not couple with shaft/bit.Coupler damaged is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Functional test: since the mating screwdriver was not received, a functional test was not performed.Although, movement of sleeve was checked on returned complaint device.It was noticed that the sleeve was slightly loose which may caused the reported condition.Dimensional inspection: dimensional analysis showed that the shaft diameter proximal to the quick coupling insert measured and falls within specification based on relevant drawing.And also internal diameter is measured using the gauge pin which falls within specification based on relevant drawing.Document/specification review: relevant drawings for the returned device were reviewed and determined to be suitable for the intended design and application when used as recommended.No design issues were observed.Investigation conclusion: the complaint of handle with mini quick coupling is confirmed with investigation.A root cause could not be determined during investigation, it is possible that the repeated usage and service may have contributed to the complaint condition.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.A device history record (dhr) review was conducted: part # 311.01.Synthes lot # a4gq656.Supplier lot # na.Release to warehouse date: 29 dec 1997.Manufactured by synthes exton.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.
 
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.Additional narrative: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 Key8950634
MDR Text Key195558044
Report Number2939274-2019-60247
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 08/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
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 NumberA4GQ656
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2019
Date Manufacturer Received10/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK - SCREWDRIVERS: SHAFTS
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