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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP2 PAT PLANER BLDE/CTR DRL MD; DRILLS (BITS, SLEEVES, GUIDES) : DRILL GUIDES
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DEPUY ORTHOPAEDICS INC US SP2 PAT PLANER BLDE/CTR DRL MD; DRILLS (BITS, SLEEVES, GUIDES) : DRILL GUIDES Back to Search Results
Model Number 97-6747
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); No Code Available (3191)
Date of Event 07/11/2016
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
Complaint description: patient was revised to address infection.
 
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Brand Name
SP2 PAT PLANER BLDE/CTR DRL MD
Common Device Name
DRILLS (BITS, SLEEVES, GUIDES) : DRILL GUIDES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key9440297
Report Number1818910-2019-121817
Device Sequence Number11495408
Product Code HTW
UDI-Device Identifier10603295251453
UDI-Public10603295251453
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2016
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 11/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number97-6747
Device Catalogue Number976747
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/15/2019
Supplement Date Received by Manufacturer03/10/2021
Initial Report FDA Received Date12/09/2019
Supplement Report FDA Received Date03/23/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age57 YR
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