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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET 3I; WRENCH
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BIOMET 3I; WRENCH Back to Search Results
Device Problem Mechanical Problem (1384)
Patient Problem No Information (3190)
Event Date 11/04/2019
Event Type  Injury  
Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
 
Event Description
It was reported that the ratchet wrench damaged the internal connection of the implant.The implant was removed.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number was not provided.Therefore, a device history review and complaint history review could not be completed.The driver was not returned and is therefore non-verifiable.However the returned implant was returned and was confirmed to have been damaged in the drive feature.A root cause cannot be determined.The following sections have been updated: b4: date of this report.G4: date received by manufacturer.G7: checked "follow-up".H2: checked follow-up type.H6: entered evaluation codes.H10: added manufacturer narrative.
 
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Type of Device
WRENCH
Manufacturer (Section D)
BIOMET 3I
4555 riverside drive
palm beach gardens FL 33410
MDR Report Key9656280
MDR Text Key177367730
Report Number0001038806-2020-00243
Device Sequence Number1
Product Code HXC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 04/08/2020
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? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/07/2020
Initial Date FDA Received02/01/2020
Supplement Dates Manufacturer Received03/12/2020
Supplement Dates FDA Received04/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
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