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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR FLEXDRILL BIT 3.2X30; HIP INSTRUMENT

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ZIMMER BIOMET, INC. MODULAR FLEXDRILL BIT 3.2X30; HIP INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/14/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Report source (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that during a hip procedure, the drill bit broke upon contact.Another drill was used to complete the surgery.No known adverse event was reported.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
No additional event information to report at this time.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed.Visual inspection identified that the drill bit fractured into two pieces.The device exhibited circumferential grooves and damage on the shank.The cutting edges were dull and damaged.Dimensional analysis was not performed as the damage was too severe.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
MODULAR FLEXDRILL BIT 3.2X30
Type of Device
HIP INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8964288
MDR Text Key156720527
Report Number0001822565-2019-03819
Device Sequence Number1
Product Code HTW
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/25/2019
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 NumberN/A
Device Catalogue Number00879000703
Device Lot Number62848576
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/16/2019
Initial Date FDA Received09/05/2019
Supplement Dates Manufacturer Received09/17/2019
Supplement Dates FDA Received09/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
UNKNOWN SCREW
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