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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER T8; SCREWDRIVERS
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER T8; SCREWDRIVERS Back to Search Results
Catalog Number 03.110.007
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
It is unknown when device became stripped.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter email address is unavailable.Without a lot number the device history records review could not be completed.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 from (b)(6) that during an unknown procedure on (b)(6) 2018, the stardrive screwdriver was stripped.It was also noted that the stardrive screwdriver does not retain screws when used.Surgeon refused to use the stardrive screwdriver.The procedure was completed successfully.It is unknown if there was a surgical delay.Patient outcome is acceptable.Concomitant devices: trauma screws (part: unknown, lot: unknown, quantity: unknown).This report is for a stardrive screwdriver t8.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 review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.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:03.110.007; synthes lot: 7016407; supplier lot: n/a; release to warehouse date: september 07, 2012; expiration date: n/a; manufactured by synthes jennersville; no nonconformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Customer quality investigation: the following investigations were performed: device interaction & damage: appearance not as expected: device condition: visual inspection performed at customer quality (cq) observed the tip of the screwdriver was twisted in the direction of screw insertion.The tips ends were observed to deformed which could have possibly caused the screw retainment issue.No new issues were identified on the other portions of the device.Functional inspection and complaint condition replication was not able to be performed to confirm the screw retainment as the mating device was not received.Furthermore, due to twisted tip conditions replication of complaint condition is not possible.However, with the malfunctions identified, the returned device condition is consistent with the given complaint description; therefore, the complaint was confirmed.Drawing review: relevant drawings for the returned instrument were reviewed (both current and from the time of manufacture): t8 one piece screwdriver.Dimensional analysis was not able to be performed due to significant post manufacture damage at tips in the form of twisting.Lot number review: a review of the device history records showed that there were no issues at the time of manufacturing of this device and its sub components that would contribute to the complaint condition.No ncrs were generated during the production of this device.Conclusion: while it is possible that any unintended excessive forces could have caused to complaint condition, a definitive root cause for the given complaint condition could not be determined from the provided information.During the investigation no unidentified issues were found.The overall complaint condition is confirmed; however, no product design issues or manufacturing discrepancies were identified during this investigation therefore, 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
STARDRIVE SCREWDRIVER T8
Type of Device
SCREWDRIVERS
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key7621054
MDR Text Key112206454
Report Number2939274-2018-52561
Device Sequence Number1
Product Code HXX
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,foreig
Type of Report Initial,Followup,Followup
Report Date 05/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.110.007
Device Lot Number7016407
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2018
Date Manufacturer Received08/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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