MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SPOT 15X60 ANATOMIC PORT; RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Catalog Number	282915560
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from depuy synthes reports an event in china as follows: it was reported that during the procedure on october 21, 2023, it was noted that the front end of the device channel was loose and rotatable.It was changed to another one to complete the procedure.There was no patient harm or surgical delay.This report is for one (1) spot 15x60 anatomic port this is report 1 of 1 for complaint (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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.
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.H6: photo investigation: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the device 282915560, spot 15x60 anatomic port was found with front end of the device channel was loose.Based on the available evidence, a definitive root cause could not be determined.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the device 282915560, spot 15x60 anatomic port would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.A review of the receiving inspection (ri) for spot 15x60 anatomic port, was conducted identifying that lot number po34108 was released in two batches.Batch1: lot qty of (b)(4) were released on june 07,2021 with no discrepancies.Batch2: lot qty of (b)(4) were released on july 01,2021 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.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: SPOT 15X60 ANATOMIC PORT
• Common Device Name: RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 18135928
• Report Number: 1526439-2023-02317
• Device Sequence Number: 7999675
• Product Code: GZT
• UDI-Device Identifier: 10705034206189
• UDI-Public: (01)10705034206189
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062814
• 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: Physician
• Type of Report: Initial,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 Catalogue Number: 282915560
• Device Lot Number: PO34108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• 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