MAUDE Adverse Event Report: DEPUY SPINE INC POLY SCREW DRIVER RETEN SLEEVE; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	2020-00-401
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Additional narrative: additional pro-codes: olo complainant part is not expected to be returned for manufacturer review/investigation.State: (b)(6).Reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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 depuy synthes reports an event in canada as follows: it was reported that during assembly for a case, it was noted by the scrub nurse and later confirmed by rep that one of the x20 screwdriver and sleeve did not assemble properly.The shaft gave significant resistance when being inserted through sleeve.The shaft appears to be slightly bent, causing issues when trying to pass through sleeve.Both shaft and sleeve set aside and note used.Navigated drivers were used, no case impact.This complaint involves two (2) devices.This report is for one (1) poly screw driver reten sleeve.This is report 1 of 2 for complaint (b)(4).

• Brand Name: POLY SCREW DRIVER RETEN SLEEVE
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 16989228
• Report Number: 1526439-2023-00898
• Device Sequence Number: 6931732
• Product Code: GEA
• UDI-Device Identifier: 10705034532776
• UDI-Public: (01)10705034532776
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 2020-00-401
• Device Catalogue Number: 202000401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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