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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 6.0 MM DIAMETER CANCELLOUS SCREW - BLACK PARTIALLY THREADED 3.5 MM HEX HEAD PROSTHESIS, TRAUMA

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ZIMMER BIOMET, INC. 6.0 MM DIAMETER CANCELLOUS SCREW - BLACK PARTIALLY THREADED 3.5 MM HEX HEAD PROSTHESIS, TRAUMA Back to Search Results
Catalog Number 47248310560
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Report source: 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 that during a procedure approximately three weeks ago, the surgeon opened the outer packaging of the screw to discover the screw broken through the inner sterile packaging. Surgeon used a backup screw to complete the surgery. Attempts have been made and no further information has been provided.
 
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Brand Name6.0 MM DIAMETER CANCELLOUS SCREW - BLACK PARTIALLY THREADED 3.5 MM HEX HEAD
Type of DevicePROSTHESIS, 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 Key12569027
MDR Text Key274517850
Report Number0001822565-2021-02841
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K083497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number47248310560
Device Lot Number62462893
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberNI

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