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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 1.8MM DRILL BIT/QC/100MM; DRILL, BONE, POWERED

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SYNTHES GMBH 1.8MM DRILL BIT/QC/100MM; DRILL, BONE, POWERED Back to Search Results
Catalog Number 310.510
Device Problem Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2022
Event Type  malfunction  
Event Description
Device report from synthes reports an event in colombia as follows: it was reported that on (b)(6) 2022, the specialist stated that the drill no longer has a good cut.There was no surgical delay in relation to the event.No further information is available.This report involves one 1.8mm drill bit/qc/100mm.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.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.Part # 310.510.Synthes lot # u391888.Supplier lot # u391888.Release to warehouse date: 05 oct 2021.Supplier: (b)(4).No non-conformance reports 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.Product was not returned.Based on the information available, it has been determined that no corrective and 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.D9: complainant part is not expected to be returned for manufacturer review/investigation.
 
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Brand Name
1.8MM DRILL BIT/QC/100MM
Type of Device
DRILL, BONE, POWERED
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ   2545
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key15987550
MDR Text Key308232324
Report Number8030965-2022-11163
Device Sequence Number1
Product Code DZI
UDI-Device Identifier07611819018808
UDI-Public(01)07611819018808
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K043310
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
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 Number310.510
Device Lot NumberU391.888
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/24/2022
Initial Date FDA Received12/15/2022
Supplement Dates Manufacturer Received12/20/2022
Supplement Dates FDA Received01/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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