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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK FIXATION PIN; FIXATION PINS
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DEPUY ORTHOPAEDICS INC US UNK FIXATION PIN; FIXATION PINS Back to Search Results
Catalog Number UNK FIXATION PIN
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2020
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 an unknown drill pin won't go through the holes of an attune distal femoral cutting block.There was no surgical delay reported.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the pin was not received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot a worldwide complaint database search was not possible as the required product code and lot number were not provided.
 
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Brand Name
UNK FIXATION PIN
Type of Device
FIXATION PINS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10941437
MDR Text Key221297341
Report Number1818910-2020-26072
Device Sequence Number1
Product Code JDW
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 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK FIXATION PIN
Was Device Available for Evaluation? No
Date Manufacturer Received12/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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