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

Catalog Number	274641000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 or Problem Description
Instrument broken in two parts was delivered direct to product safety (b)(6) 2017 from (b)(6) hospital with no complaint attached.Jnj rep became aware of missing item (b)(6) 2017 and obtaining the following details from customer: the rod cutter was broken when a registrar was using it to cut a rod insitu (already in a patient).From what jnj rep knows the rod was not a mountaineer rod.The registrar was having difficulty and the staff were looking for an instrument to cut the rod insitu.It was broken in the process.The rod cutter belongs on a consigned mountaineer.Image of broken instrument as received (b)(6) 2017 on file.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination at the macroscopic level revealed that the fracture was located at one of the rod cutter¿s jaws.Device was then sent for fracture analysis.The fracture analysis report shows rough grainy appearances consistent across the entirety of the surface which suggests that the rod cutter underwent a quasi-static overload failure.No material defects or other abnormalities have been identified in the fracture analysis report.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause for the rod cutter¿s jaw becoming fractured cannot be positively determined.However, the fracture analysis report shows rough grainy appearances consistent across the entirety of the surface which suggests that the rod cutter underwent a quasi-static overload failure.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PEAK 3.0MM FIXATION ROD CUTTER
• Common Device Name: INSTRUMENT, CUTTING, ORTHOPEDIC
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7130628
• Report Number: 1526439-2017-50100
• Device Sequence Number: 11185171
• Product Code: HTZ
• UDI-Device Identifier: 10705034192918
• UDI-Public: 10705034192918
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 274641000
• Device Lot Number: KM858642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1