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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. INSTRUMENT, TRAUMA

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ZIMMER BIOMET, INC. CEPHALOMEDULLARY LAG SCREW REAMER LONG 3.2 MM I.D. INSTRUMENT, TRAUMA Back to Search Results
Catalog Number 00249003244
Device Problems Fracture (1260); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/21/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Report source: foreign - event occurred in (b)(6). 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. 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.
 
Event Description
It was reported during the surgery, the distal part of the reamer broke. All pieces were found. No piece remain into the patient body. The carbon guide may have been bent while introducing the guide wire. Attempts have been made and no further information has been provided.
 
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Brand NameCEPHALOMEDULLARY LAG SCREW REAMER LONG 3.2 MM I.D.
Type of DeviceINSTRUMENT, TRAUMA
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 Key13719339
MDR Text Key286926394
Report Number0001822565-2022-00688
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00249003244
Device Lot Number64196765
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberNI

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