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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MEDIAL PORTAL AIMER 7MM INSTRUMENT, SURGICAL

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ZIMMER BIOMET, INC. MEDIAL PORTAL AIMER 7MM INSTRUMENT, SURGICAL Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 01/30/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Unique identifier (udi)#: n/a. Report source: event occurred in (b)(6).
 
Event Description
It was reported that during an arthroscopic r knee surgery with acl reconstruction, the tip of the aimer had fractured. The fractured piece fell into the patient's joint and was left in situ. Attempts have been made and no other further information has been provided.
 
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Brand NameMEDIAL PORTAL AIMER 7MM
Type of DeviceINSTRUMENT, SURGICAL
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8343974
MDR Text Key136286933
Report Number0001825034-2019-00645
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number909591
Device Lot Number312910
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/15/2019 Patient Sequence Number: 1
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