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

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.

• Brand Name: PEAK 3.0MM FIXATION ROD CUTTER
• Type of Device: INSTRUMENT, 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 Key: 8865722
• MDR Text Key: 179323148
• Report Number: 1526439-2019-51940
• Device Sequence Number: 1
• Product Code: HTZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Received: 08/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 274641000
• Device Catalogue Number: 274641000
• Device Lot Number: KM646313
• 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 Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown