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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK DRILL/DRIVER SHAFT; DRILL/DRIVE SHAFT
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DEPUY ORTHOPAEDICS INC US UNK DRILL/DRIVER SHAFT; DRILL/DRIVE SHAFT Back to Search Results
Catalog Number UNK DRILL/DRIVER SHAFT
Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/07/2022
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (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 surgeon harvested bone graph from the right femur using retrograde approach.The intramedullary canal was tight and it appeared to require a fair amount of force to advance the reamer, however this was done successfully.The surgeon then went to reteam the left tibia with the same ria2 setup.Upon removal of the ria2 from the intramedullary canal it was noted that a piece of plastic was missing from the distal portion of the disposable drive shaft assembly.
 
Manufacturer Narrative
Product complaint # (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 surgeon harvested bone graph from the right femur using retrograde approach.The intramedullary canal was tight and it appeared to require a fair amount of force to advance the reamer, however this was done successfully.The surgeon then went to reteam the left tibia with the same ria2 setup.Upon removal of the ria2 from the intramedullary canal it was noted that a piece of plastic was missing from the distal portion of the disposable drive shaft assembly.
 
Manufacturer Narrative
Product complaint (b)(4).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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
 
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Brand Name
UNK DRILL/DRIVER SHAFT
Type of Device
DRILL/DRIVE SHAFT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13583827
MDR Text Key285999445
Report Number1818910-2022-03320
Device Sequence Number1
Product Code HTW
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 02/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK DRILL/DRIVER SHAFT
Device Lot Number481P659
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age20 YR
Patient SexFemale
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