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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SHAFT FOR 90° SCREWDRIVER; DRILL, BONE, POWERED
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC SHAFT FOR 90° SCREWDRIVER; DRILL, BONE, POWERED Back to Search Results
Model Number 03.505.003
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
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.Additional product codes: dzj, hxx.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 that on an unknown date, during an unknown procedure, the 90 degree driver would not lock in screw and kept spinning.It is unknown if there was any surgical delay.There was no patient consequence.This complaint involves one (1) device.This report is 2 of 2 for (b)(4).
 
Event Description
Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown); unknown plate (part# unknown, lot# unknown, quantity#1).
 
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.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.H3, h4, h6: a device history record (dhr) review was conducted: part: 03.505.003, lot: 8152686, manufacturing site: selzach, supplier: diener ag, release to warehouse date: 26.Apr.2016.The device history record shows this lot of 100 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.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.H3, h6: a product investigation was conducted.Device evaluation:investigation flow: visual (appearance not as expected) visual inspection: the shaft for 90° screwdriver (part number 03.505.003, lot number 8152686) was returned to us customer quality.Along with the shaft, handle for 90° screwdriver (part number 03.505.004, lot number 8165482) the was returned.Upon visual inspection, it was noted that the screwdriver/shaft assembly was missing the following components - insert gear, gear cover, screw holder and the turning handle.The balance of the device shows surface wear consistent with use and which would not impact the functionality.Functional test: as all of the assembly components were not returned, a complete functional test could not be performed.However, a partial functional test was performed.The pre-assembled shaft axle was inserted into the screw driver.No functional issues were noted with the any returned part.The devices was found to fully assemble and disassemble as intended.The complaint condition cannot be replicated with the returned device and therefore the reported condition was not confirmed.However, the overall complaint is confirmed due to the missing components.Document/specification review: the relevant drawings was reviewed: no product design issues or discrepancies were observed.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.Dimensional inspection: a dimensional inspection was not performed as the missing sub-components relevant to the complaint condition were missing/ not returned.In addition, as the device was found to function as intended, dimensional inspection is not relevant.Conclusion: the complaint condition cannot be replicated due to missing sub-components.We can only assume that during use the screwdriver shaft was not fully inserted into the screw recess.However, it is likely that any possible off-axis forces encountered by the device during alignment could have contributed to this complaint condition.The reported condition is unconfirmed as the device functioned as intended.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown and the complaint condition could not be replicated.No design or manufacturing defect or deficiency was observed during the 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.
 
Event Description
T was reported that on an unknown date, during an unknown procedure, the 90 degree screwdriver would not lock in screw and kept spinning, it was being inserted and would not lock into the plate.It is unknown if there was any surgical delay.There was no patient consequence.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown).
 
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Brand Name
SHAFT FOR 90° SCREWDRIVER
Type of Device
DRILL, BONE, POWERED
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key8176581
MDR Text Key130769998
Report Number2939274-2018-55453
Device Sequence Number1
Product Code DZI
UDI-Device Identifier10887587013299
UDI-Public(01)10887587013299
Combination Product (y/n)N
PMA/PMN Number
K082649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 11/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number03.505.003
Device Catalogue Number03.505.003
Device Lot Number8152686
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2018
Date Manufacturer Received01/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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