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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER CAS FIX PIN FLTD 3.2DX80MM 2 PACK ORTHOPEDIC STEREOTAXIC INSTRUMENT

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ZIMMER CAS FIX PIN FLTD 3.2DX80MM 2 PACK ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0009617840 - 2021 - 00009, 0009617840 - 2021 - 00010, 0009617840 - 2021 - 00011, 0009617840 - 2021 - 00012, 0009617840 - 2021 - 00013, 0009617840 - 2021 - 00014, 0009617840 - 2021 - 00015, 0009617840 - 2021 - 00016, 0009617840 - 2021 - 00017, 0009617840 - 2021 - 00019, 0009617840 - 2021 - 00020. 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. Product being returned.
 
Event Description
It was reported the cas fixation pin primary packaging was not correctly sealed. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameFIX PIN FLTD 3.2DX80MM 2 PACK
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
ZIMMER CAS
75 queen str.
suite 3300
montreal, quebec H3C 2 N6
CA H3C 2N6
Manufacturer (Section G)
ZIMMER CAS
75 queen str.
suite 3300
montreal, quebec H3C 2 N6
CA H3C 2N6
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key12300515
MDR Text Key265893471
Report Number0009617840-2021-00018
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K210121
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 11/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number20-8000-000-11
Device Lot Number64808899
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2020
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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