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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ORTHOLOC® DRILL BIT 1/8; KNEE INSTRUMENT
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MICROPORT ORTHOPEDICS INC. ORTHOLOC® DRILL BIT 1/8; KNEE INSTRUMENT Back to Search Results
Model Number 16109008
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 10/24/2019
Event Type  malfunction  
Manufacturer Narrative
This event will be updated when the investigation is complete.
 
Event Description
Allegedly , tip of 1/8 advance drill bit broke off in patient while drilling tibial screw holes.Approx 10mm remained in-situ.Instead of a screw being implanted into the fourth hole on the biofoam, the broken piece of the drill bit remains in place.3 screws only were implanted.(b)(6).
 
Manufacturer Narrative
The alleged complaint is confirmed.This complaint was reported by a microport distributor.The device history records were reviewed for all products listed and the products met specification at the time they were manufactured.This failure mode is listed in the device package insert and risk documentation.The instrument cleaning and handling instructions (150802-2) indicate that the instruments are susceptible to damage over time and should be inspected prior to and after each use.In addition, the cleaning and handling instructions also state, "end of functional life is normally determined by wear and damage due to use." per the incident description, the product was not returned.No images were provided for evaluation.There were no trends identified.This issue will continue to be monitored through complaint tracking.
 
Event Description
Allegedly , tip of 1/8 advance drill bit broke off in patient while drilling tibial screw holes.Approx 10mm remained in-situ.Instead of a screw being implanted into the fourth hole on the biofoam, the broken piece of the drill bit remains in place.3 screws only were implanted.
 
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Brand Name
ORTHOLOC® DRILL BIT 1/8
Type of Device
KNEE INSTRUMENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9397504
MDR Text Key190000846
Report Number3010536692-2019-01155
Device Sequence Number1
Product Code GFG
UDI-Device IdentifierM684161090081
UDI-PublicM684161090081
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number16109008
Device Catalogue Number16109008
Device Lot Number606411
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/04/2019
Date Manufacturer Received11/04/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
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