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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM; SCREWDRIVER

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SYNTHES GMBH SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM; SCREWDRIVER Back to Search Results
Catalog Number 03.019.025
Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2023
Event Type  malfunction  
Event Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6)2023, the patient underwent surgery for the humerus with the multiloc screw.When the surgeon attached the multiloc screw to the screwdriver, the rearmost of the instrument¿s components came off.After that, the surgeon made several attempts to attach it, but could not solve the problem.Finally, the surgeon inserted the multiloc screw without holding it by the screwdriver.The surgery was completed successfully with a 30-minute delay.There was no problem with bone fixation, and the patient status/outcome was reported to be stable.This report involves one scrwdrvr f/4.5mm ti multiloc screws/slf-retain/330mm.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.H3, h6: 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.
 
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.D9: device returned.H3, h6: 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: part# 03.019.025 lot # l935928 manufacturing site: werk hagendorf supplier: na release to warehouse date: 14 sep 2018 expiration date: na a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual analysis of the returned sample revealed that scrdriver f/multiloc scr ø4.5 w/selfhold had shaft component knob fallen off.The fallen part was returned.With the knob fallen off the shaft, it is not possible to disassemble the shaft from the main body as as intended.The reported complaint condition was confirmed.A dimensional inspection was not performed since it was not applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the scrdriver f/multiloc scr ø4.5 w/selfhold would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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
SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM
Type of Device
SCREWDRIVER
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf CO 4614
SZ   4614
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key16876019
MDR Text Key314633219
Report Number8030965-2023-05825
Device Sequence Number1
Product Code HXX
UDI-Device Identifier07611819427259
UDI-Public(01)07611819427259
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.019.025
Device Lot NumberL935928
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/14/2023
Initial Date FDA Received05/05/2023
Supplement Dates Manufacturer Received06/05/2023
07/10/2023
Supplement Dates FDA Received06/23/2023
07/11/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/14/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
UNK - NAIL HEAD ELEMENTS: MULTILOC HUMERAL SCREW
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