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

Catalog Number	274641000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
It was reported surgeon was trying to cut a rod after it was locked down in the occipital plate.He put the cutter on the rod and attempted to cut it.The cutter broke and didn¿t cut rod.The cutter fragment was retrieved and disposed.He then got a metal cutting burr and cut rod.Ten minute delay reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination at the macroscopic level revealed that the tip of one jaw was completely fractured and not returned for analysis.A crack was also observed in the other jaw.Device was then sent for fracture analysis.The fracture analysis report shows that the fractured surface exhibits a rough grainy appearance consistent across the entirety of the surface which suggests that the rod cutter jaw underwent a quasi-static overload failure.No material defects or other abnormalities were observed in this analysis.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the rod cutter¿s jaw tip becoming fractured cannot be positively determined.However, the fracture analysis report suggests that the rod cutter jaw 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Device was not returned for evaluation.A review of the device history record could not be performed as the lot number was not provided.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.As no systemic trends were found, this complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.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 SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7238041
• Report Number: 1526439-2018-50100
• Device Sequence Number: 10959032
• Product Code: HTZ
• UDI-Device Identifier: 10705034192918
• UDI-Public: 10705034192918
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 01/22/2018

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: KM646313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 02/28/2018; 03/23/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 02/28/2018; 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR