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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 METAGLENE HOLDER INTERNAL ROD; EXTREMITY INSTRUMENTS : HANDLES

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DEPUY IRELAND 9616671 METAGLENE HOLDER INTERNAL ROD; EXTREMITY INSTRUMENTS : HANDLES Back to Search Results
Model Number 2307-87-002
Device Problems Material Twisted/Bent (2981); Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2021
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 metaglene inserter does not soundly hold the metaglene.A surgical delay of 5 minutes.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
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Brand Name
METAGLENE HOLDER INTERNAL ROD
Type of Device
EXTREMITY INSTRUMENTS : HANDLES
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI 
MDR Report Key11748104
MDR Text Key248159126
Report Number1818910-2021-09203
Device Sequence Number1
Product Code HWA
UDI-Device Identifier10603295116431
UDI-Public10603295116431
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 04/14/2021
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 Number2307-87-002
Device Catalogue Number230787002
Device Lot Number5246066
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/14/2021
Initial Date FDA Received04/29/2021
Supplement Dates Manufacturer Received06/09/2021
Supplement Dates FDA Received06/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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