MAUDE Adverse Event Report: DEPUY SPINE INC MMSI ROD STABILIZER; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number 279712500

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported during a spine fusion procedure on (b)(6) 2020, the expedium rod stabilizers were damaged/worn at the distal end tip and did not work appropriately during the surgery.This issue prevented adequate counter torque force in performing the final tightening.The surgery was completed successfully with no surgical delay this is report 3 of 3 for (b)(4).

• Brand Name: MMSI ROD STABILIZER
• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10727522
• MDR Text Key: 212758379
• Report Number: 1526439-2020-02032
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10705034198958
• UDI-Public: (01)10705034198958
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279712500
• Device Catalogue Number: 279712500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1