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 Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Reporter is a synthes employee.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported on an unknown date, during surgery, the surgeon attempted to cut the overhang of a 3.5mm rod insitu after final tightening was already performed on a c3 - c7 construct.The overhang was located at the c3 level.The tip of the rod cutter broke apart into the patient.The surgeon was able to locate and remove all broken pieces and continued with the surgery.Fragments generated is unknown.Surgical delay is unknown.There were no patient consequences.The procedure outcome is unknown.Concomitant device reported: unknown rod (part#: unknown, lot#: unknown, quantity: unknown).This complaint involves one (1) device.This 1 of 1 report for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The peak 3.0mm fixation rod cutter (part # 274641000/ lot # km646313) was received at us cq.The distal tip of both jaws were broken.The break was oblique in nature, no fragments were returned.The received condition was consistent with the complaint condition thus the complaint was confirmed.The overall complaint was confirmed for the received peak 3.0mm fixation rod cutter.Although no definitive root-cause can be determined it¿s possible the device encountered unintended forces while in use.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot a review of the receiving inspection (ri) for peak 3.0mm fixation rod cutter was conducted identifying that lot number km646313 was released in a single batch.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device was used for treatment, not diagnosis.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
• Type of Device: INSTRUMENT, CUTTING, ORTHOPEDIC
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9677974
• MDR Text Key: 178231616
• Report Number: 1526439-2020-00505
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10705034192918
• UDI-Public: (01)10705034192918
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 274641000
• Device Catalogue Number: 274641000
• Device Lot Number: KM646313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1