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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH HANDLE WITH QUICK COUPLING, SMALL; TAP, BONE

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SYNTHES GMBH HANDLE WITH QUICK COUPLING, SMALL; TAP, BONE Back to Search Results
Model Number 311.43
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2022
Event Type  malfunction  
Event Description
It was reported that on an unknown date, the screwdriver and the handle got stuck and unable to remove.There was no patient involvement.This report is for one (1) handle with quick coupling, small.This is report 2 of 2 for complaint (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.Initial reporter is a j&j sales representative.The device has been 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.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that handle with quick coupling, small arrived assembled to the mating device sddrive screwdriver shaft qc/t15 (314.116).No other issues were found.A dimensional inspection for the handle with quick coupling, small was not performed as it is not applicable to the complaint condition.A functional test was performed, but it was not possible to disassemble the screwdriver.The complaint condition was able to be replicated.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 handle with quick coupling, small 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.Drawing/specifications reviewed? yes, reviewed dimensional inspection: n/a device history part # 311.43 synthes lot # 6439907 supplier lot # n/a release to warehouse date: 06 aug 2010 manufactured by: synthes brandywine.No ncrs 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.
 
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Brand Name
HANDLE WITH QUICK COUPLING, SMALL
Type of Device
TAP, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key16214760
MDR Text Key308948915
Report Number8030965-2023-00691
Device Sequence Number1
Product Code HWX
UDI-Device Identifier10886982187390
UDI-Public(01)10886982187390
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,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 Model Number311.43
Device Catalogue Number311.43
Device Lot Number6439907
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/26/2022
Initial Date FDA Received01/20/2023
Supplement Dates Manufacturer Received02/09/2023
Supplement Dates FDA Received02/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/06/2010
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
SDDRIVE SCREWDRIVER SHAFT QC/T15; SDDRIVE SCREWDRIVER SHAFT QC/T15
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