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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.3MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 8MM; SCREW, FIXATION, BONE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.3MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 8MM; SCREW, FIXATION, BONE Back to Search Results
Model Number 02.130.008
Device Problem Device Handling Problem (3265)
Patient Problem No Patient Involvement (2645)
Event Date 06/04/2019
Event Type  malfunction  
Manufacturer Narrative
Additional pro-code: hrs.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; 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.
 
Event Description
It was reported that on (b)(6) 2019, the patient had a revision of fifth metacarpal and fourth proximal phalanx that was performed last week wherein the cortex screws would not hold on to the unknown screwdriver.They were able to get the couple in but the other three (3) would not stay on the screwdriver.Wherein three (3) screws were successfully implanted and they were cortex.There were no issue with the screwdriver.Surgical delay of ten (10) minutes to get screws to stay on.Procedure was successfully completed.There were no other devices involved.There was no damage to the patient.Concomitant device reported: unknown screwdriver (part # unknown, lot # unknown, quantity# 1), 1.3 mm cortex screw self-taping with t4 stardrive recess 8 mm (part # 02.130.108, lot # unknown, quantity# 3).This complaint involves three (3) devices.This report is 2 of 3 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.Corrected concomitant device.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
Concomitant device reported: unknown screwdriver (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: a product investigation was conducted.Visual inspection: the 1.3mm cortex screw slf-tpng with t4 stardrive recess 8mm (p/n 02.130.008 lot unk) was received showing no defects or deformities along the entire screw.No issues were identified with the stardrive head/recess.The screw was inspected under 10x magnification.Functional inspection: functional testing could not be completed as the mating screwdriver was not received.The reported complaint condition could not be replicated as the mating screwdriver was not received.Dimensional inspection: dimensional inspection was not conducted as no device failure/defects/deformities were observed and no relevant device features contributing to the complaint condition was found.Document/specification review: a dhr review could not be performed as the lot number is unknown.The relevant drawing, reflecting the current revision, was reviewed, since the exact manufacturing date is unknown.Per drawing, no part/lot etch design is manufactured on the screw.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is unconfirmed for the 1.3mm cortex screw slf-tpng with t4 stardrive recess 8mm (p/n 02.130.008 lot unk) as no defects or deformities were found along the entire screw.No relevant device features contributing to the complaint condition was found.The screw was inspected under 10x magnification.While no definitive root cause could be determined for the reported complaint, it is possible that the condition was due to surgeon handling and/or screwdriver use.During this investigation no product design or manufacturing issues 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.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
1.3MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 8MM
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key8769813
MDR Text Key150677132
Report Number2939274-2019-59060
Device Sequence Number1
Product Code HWC
UDI-Device Identifier10886982044143
UDI-Public(01)10886982044143
Combination Product (y/n)N
PMA/PMN Number
K150099
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 06/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number02.130.008
Device Catalogue Number02.130.008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2019
Date Manufacturer Received07/31/2019
Patient Sequence Number1
Treatment
UNK - SCREWDRIVERS
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