MAUDE Adverse Event Report: DEPUY SPINE INC SI APPROXIMATOR SLEEVE; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	279763660
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).Complainant device is not expected to be returned for manufacturer review/investigation.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on an unknown date, during and unknown procedure the outer sleeve of reduction tower was bent during rod reduction.Surgical delay is unknown.There were no patient consequences.Procedure outcome is unknown.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: SI APPROXIMATOR SLEEVE
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11648279
• Report Number: 1526439-2021-00690
• Device Sequence Number: 11637093
• Product Code: GEA
• UDI-Device Identifier: 10705034201054
• UDI-Public: (01)10705034201054
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

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: 279763660
• Device Catalogue Number: 279763660
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1