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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC SYMPHONY OCT SYSTEM ROD CUTTER FOR 3.5MM AND 4.0MM RODS INSTRUMENT, CUTTING, ORTHOPEDIC

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DEPUY SPINE INC SYMPHONY OCT SYSTEM ROD CUTTER FOR 3.5MM AND 4.0MM RODS INSTRUMENT, CUTTING, ORTHOPEDIC Back to Search Results
Model Number 2020-00-135
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2021
Event Type  malfunction  
Event Description
It was reported that on (b)(6) 2021, during an unknown procedure a crack in the tip of the rod cutter was noticed. The issue was found after it was used to cut a rod. There were no fragments generated. Procedure was successfully completed with no surgical delay. There was no patient consequences. There is no further information available. This report is for one (1) symphony oct system rod cutter for 3. 5mm and 4. 0mm rods. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NameSYMPHONY OCT SYSTEM ROD CUTTER FOR 3.5MM AND 4.0MM RODS
Type of DeviceINSTRUMENT, CUTTING, ORTHOPEDIC
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
BRIDGEWATER DISTRIBUTION
50 scotland boulevard
bridgewater MA 02324
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key13129386
MDR Text Key285334862
Report Number1526439-2021-02681
Device Sequence Number1
Product Code HTZ
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2020-00-135
Device Catalogue Number202000135
Device Lot NumberGS676412
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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