MAUDE Adverse Event Report: DEPUY SPINE INC POLY SCREW DRIVER RETEN SLEEVE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	202000401
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
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, 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.E3: reporter is a j&j sales representative.H3, h4, h6: a review of the receiving inspection (ri) for poly screw driver reten sleeve was conducted identifying that lot number pc5315848 was released in one batch.Batch 1: (b)(4).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.H6: photo investigation: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that poly screw driver reten sleeve had the complaint condition of symphony driver shaft and outer sleeve became stuck together could not be verified.Review of provided photo does not confirms the reported condition.Without having actual device for evaluation and functional test of unable to assemble performed on the device, reported event remains unconfirmed and cause remains undetermined.The overall complaint was unconfirmed as the observed condition of the poly screw driver reten sleeve would not contribute to the complained device issue.Based on the investigation findings, potential cause cannot be established and 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.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
It was reported that on an unknown date, symphony driver shaft and outer sleeve became stuck together.It was almost impossible to separate.Driver possibly was bent.Procedure and patient outcome were unknown.This report is for one (1) poly screw driver reten sleeve.This is report 1 of 2 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.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.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 device found, that the poly screw driver reten sleeve has signs of became stuck with the poly screw driver shaft x20.Also, has a difficulty to be disassemble/assemble.Functional test was performed with a mating device and was a difficulty to disassemble/assemble.Was able to replicate the reported allegation.The observed, condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.A dimensional inspection was not performed, since it was not applicable to the complaint condition.The overall complaint was confirmed, as the observed, condition of the poly screw driver reten sleeve would contribute to the complained device issue.There is no indication, that a design or manufacturing issue has caused the complaint condition.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.As part of depuy synthes quality process, all devices are manufactured, inspected and released to approved specifications.If information is obtained, that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: POLY SCREW DRIVER RETEN SLEEVE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 17821892
• Report Number: 1526439-2023-01823
• Device Sequence Number: 12296641
• Product Code: OLO
• UDI-Device Identifier: 10705034532776
• UDI-Public: (01)10705034532776
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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 Catalogue Number: 202000401
• Device Lot Number: PC5315848
• 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: 09/11/2023
• Supplement Date Received by Manufacturer: 09/28/2023; 10/25/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/16/2023; 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: POLY SCREW DRIVER SHFT X20
• Patient Sex: Unknown