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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. CORTICAL BONE SCREW SELF-TAPPING HEX HEAD 3.5 MM DIAMETER 46 MM LENGTH PLATE, FIXATION

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ZIMMER MANUFACTURING B.V. CORTICAL BONE SCREW SELF-TAPPING HEX HEAD 3.5 MM DIAMETER 46 MM LENGTH PLATE, FIXATION Back to Search Results
Catalog Number 00234702046
Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Foreign - event occurred in (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested but not available for return. The investigation is in process. 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 fixation of a plate, the threads of the screw were damaged due to the angle of implantation causing it to run into another screw. The screw was removed and a new one was used to complete the surgery. Attempts have been made and no further information has been provided.
 
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Brand NameCORTICAL BONE SCREW SELF-TAPPING HEX HEAD 3.5 MM DIAMETER 46 MM LENGTH
Type of DevicePLATE, FIXATION
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer (Section G)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key12917266
MDR Text Key283088006
Report Number0002648920-2021-00432
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K142579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00234702046
Device Lot Number62166452
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/11/2012
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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