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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
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
Rod cutter was left in sterile core after it had been removed from the mountaineer instrument set.We were not present during a case where this instrument was broken, nor did any hospital staff have any knowledge of this instrument breaking.The tip of the cutter broke off and we do not have this piece in our possession.Patient consequence? :no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
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 suggests that the rod cutter jaw underwent a quasi-static overload failure.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 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.

• 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: 7211762
• Report Number: 1526439-2018-50060
• Device Sequence Number: 10980069
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018

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: 01/10/2018
• Initial Date Received by Manufacturer: 01/04/2018
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 01/23/2018
• Supplement Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1