MAUDE Adverse Event Report: DEPUY SPINE INC ISOLA SPINE SYSTEM ROD CUTTER (SIDE); INSTRUMENT, CUTTING, ORTHOPEDIC

Model Number 205027

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

A product investigation was completed: upon visual inspection, it is observed that one corner of the cutting edges got slightly broken.Rest of the cutting edges got slightly worn.Thus, the complaint is being confirmed.Dimensional inspection of the received device was not performed due to post manufacturing damage.The relevant drawings were reviewed; no design issues or discrepancies were found during this investigation.The complaint is being confirmed as one corner of the cutting edges got slightly broken.While a definitive root cause could not be identified for the reported problem, it is possible that the device might have encountered unintended forces.The worn condition might have caused due to repeated use and service.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 upon these results, 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 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

Device report from synthes (b)(6) reports an event as follows: it was reported the cutting blades of the rod cutter were not cutting anymore.There was not patient or procedure impact.Upon visual inspection of the received device, it is observed that one corner of the cutting edges got slightly broken.Rest of the cutting edges got slightly worn.This report is for a rod cutter.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Is rod side cutter (part# 205027, lot# h440083, qty# (b)(4)) was returned and received at us cq.Upon visual inspection at cq, it is observed that one corner of the cutting edges got slightly broken.Rest of the cutting edges got slightly worn.Thus, the complaint is being confirmed.The complaint is being confirmed for is rod side cutter (part# 205027, lot# h440083) as one corner of the cutting edges got slightly broken.While a definitive root cause could not be identified for the reported problem, it is possible that the device might have encountered unintended forces.The worn condition might have caused due to repeated use and service.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 upon these results, 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: the possible root cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required.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: ISOLA SPINE SYSTEM ROD CUTTER (SIDE)
• Type of Device: INSTRUMENT, CUTTING, ORTHOPEDIC
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11801529
• MDR Text Key: 250970824
• Report Number: 1526439-2021-00930
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10705034001258
• UDI-Public: (01)10705034001258
• 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
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 205027
• Device Catalogue Number: 205027
• Device Lot Number: H440083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Date Manufacturer Received: 06/22/2021
• Patient Sequence Number: 1