MAUDE Adverse Event Report: DEPUY SPINE INC SYMPHONY OCT SYSTEM ROD CUTTER FOR 3.5MM AND 4.0MM RODS; INSTRUMENT, CUTTING, ORTHOPEDIC

Model Number	2020-00-135
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2023
Type of Reportable Event	Malfunction
Additional 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.H10 additional narrative: b3: only the event month and year are known.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 or Problem Description
Device report from synthes reports an event in germany as follows: it was reported that during the cleaning process on an unknown date in april 2023, part of the cutting tool for cutting rods was broken.It is not possible to cut a rod with it.This was detected in the sterile processing department; no patient or surgery involved.This report involves one symphony oct system rod cutter for 3.5mm and 4.0mm rods.This is report 1 of 1 for (b)(4).
Additional 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.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that rod cutter 3.5 and 4.0 rods has one of the jaws broken into two pieces, fragments were returned for evaluation.Based on the damage of the device, it is reasonable that the observed breakage prevents the device from cutting as intended.No other defects were observed.A dimensional inspection for the rod cutter 3.5 and 4.0 rods was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the rod cutter 3.5 and 4.0 rods would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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.A review of the receiving inspection (ri) for rod cutter 3.5 and 4.0 rods was conducted identifying that lot number: gs741841 was released in two batch.Batch 1: lot qty of (b)(4) units were released on 30 apr 2020 with no discrepancies.Batch 2: lot qty of (b)(4) units were released on 31 aug 2020 with no discrepancies.Supplier: (b)(4).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 photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.Visual analysis of the photo revealed that one of the cutter of rod cutter 3.5 and 4.0 rods was broken, fragment was observed in the visual evidence provided.Functionality issues cannot be assessed though a photo investigation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for rod cutter 3.5 and 4.0 rods.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SYMPHONY OCT SYSTEM ROD CUTTER FOR 3.5MM AND 4.0MM RODS
• Common Device Name: INSTRUMENT, CUTTING, ORTHOPEDIC
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16929865
• Report Number: 1526439-2023-00843
• Device Sequence Number: 12496320
• Product Code: HTZ
• UDI-Device Identifier: 10705034530536
• UDI-Public: (01)10705034530536
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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 Model Number: 2020-00-135
• Device Catalogue Number: 202000135
• Device Lot Number: GS741841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 05/17/2023; 07/13/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 06/01/2023; 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown