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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. BALL TIP PROBE - DUAL ENDED STIFF/FLEXIBLE - STANDARD
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ZIMMER BIOMET SPINE INC. BALL TIP PROBE - DUAL ENDED STIFF/FLEXIBLE - STANDARD Back to Search Results
Catalog Number 07.02117.001
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2022
Event Type  malfunction  
Event Description
It was reported that a vitality probe tip broke off intra-op.The fractured tip was found on the back table and did not fall into the incision.Another probe was used to complete the case.There were no patient impacts.
 
Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
 
Manufacturer Narrative
Inspection: visual inspection revealed that the ball on one tip of the device was fractured off.The shaft of the probe was also bent.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimvie¿s control.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.This event could also be attributed to off-axis forces applied during use.Device usage: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
 
Event Description
It was reported that a vitality probe tip broke off intra-op.The fractured tip was found on the back table and did not fall into the incision.Another probe was used to complete the case.There were no patient impacts.
 
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Brand Name
BALL TIP PROBE - DUAL ENDED STIFF/FLEXIBLE - STANDARD
Type of Device
PROBE
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
na
westminster CO 80021
Manufacturer Contact
kim martinez
10225 westmoor dr.
na
westminster, CO 80021
3035144809
MDR Report Key15736016
MDR Text Key305684732
Report Number3012447612-2022-00249
Device Sequence Number1
Product Code HXB
UDI-Device Identifier00889024010550
UDI-Public(01)00889024010550(10)MC4281504
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number07.02117.001
Device Lot NumberMC4281504
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/10/2022
Initial Date FDA Received11/04/2022
Supplement Dates Manufacturer Received04/18/2023
Supplement Dates FDA Received04/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexMale
Patient Weight91 KG
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