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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC PEAK 3.0MM FIXATION ROD CUTTER INSTRUMENT, CUTTING, ORTHOPEDIC

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DEPUY SPINE INC PEAK 3.0MM FIXATION ROD CUTTER INSTRUMENT, CUTTING, ORTHOPEDIC Back to Search Results
Model Number 274641000
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/16/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device is available for evaluation. Investigation will be conducted. Follow up will be filed with the investigation results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
To whom it may concern: date j&j became aware: 16/07/19. (b)(6). Product: mountaineer rod cutter. Lot/batch/exp: km646313. Product number: 274641000. Did the event happen during a procedure? yes. Were you in the procedure at the time of the event? yes. Was the product being used in a clinical trial? no. Event outcome/how was it managed? another kit opened for replacement instruments was there a patient impact or was the procedure due to the failure? no. Has the reporter facility indicated there may be legal action? no. Is the product available for return? yes once cleaned. Please give a detailed explanation of the event: the surgeon went to cut the rod with the rod cutter and as doing so, the cutter snapped at the jaws. Surgery delayed by 5 mins while another kit was opened for a replacement instrument. Please can you send an urgent replacement to: product code 274641000. (b)(6). This complaint involves one (1) device.
 
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Brand NamePEAK 3.0MM FIXATION ROD CUTTER
Type of DeviceINSTRUMENT, CUTTING, ORTHOPEDIC
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key8865722
MDR Text Key179323148
Report Number1526439-2019-51940
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
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 07/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number274641000
Device Catalogue Number274641000
Device Lot NumberKM646313
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2011
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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