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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEPHALOMEDULLARY LAG SCREW REAMER LONG 3.2 MM I.D. ORTHOPAEDIC PROSTHESIS IMPLANTATION INSTRUMENT, REUSABLE

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ZIMMER BIOMET, INC. CEPHALOMEDULLARY LAG SCREW REAMER LONG 3.2 MM I.D. ORTHOPAEDIC PROSTHESIS IMPLANTATION INSTRUMENT, REUSABLE Back to Search Results
Catalog Number 00249003244
Device Problem Fracture (1260)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2020
Event Type  malfunction  
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.
 
Event Description
It was reported that a cm natural nail lag screw reamer fractured off in the head of the femur. There is a considerable chance that the reamer knicked a bullet fragment that was lodged in the femur. The surgeon was able to remove the entirety of the fractured piece. A new reamer was used and the case was finished successfully. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameCEPHALOMEDULLARY LAG SCREW REAMER LONG 3.2 MM I.D.
Type of DeviceORTHOPAEDIC PROSTHESIS IMPLANTATION INSTRUMENT, REUSABLE
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 Key11018926
MDR Text Key221762112
Report Number0001822565-2020-04039
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00249003244
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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