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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS BROACH SZ 4; BROACHES
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DEPUY IRELAND - 9616671 ACTIS BROACH SZ 4; BROACHES Back to Search Results
Model Number 2010-01-040
Device Problems Device-Device Incompatibility (2919); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/23/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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 the broach didn¿t fit handle.Damage to insertion point.
 
Manufacturer Narrative
Product complaint #
=
> pc-(b)(4).Investigation summary
=
> the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: added: h6 (device).
 
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Brand Name
ACTIS BROACH SZ 4
Type of Device
BROACHES
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10346208
MDR Text Key201077212
Report Number1818910-2020-17231
Device Sequence Number1
Product Code KWL
UDI-Device Identifier10603295393665
UDI-Public10603295393665
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2010-01-040
Device Catalogue Number201001040
Was Device Available for Evaluation? No
Date Manufacturer Received09/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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