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

Model Number	279712500
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 2 of 3 for (b)(4).

• Brand Name: MMSI ROD STABILIZER
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10727494
• Report Number: 1526439-2020-02031
• Device Sequence Number: 11544672
• Product Code: GEA
• UDI-Device Identifier: 10705034198958
• UDI-Public: (01)10705034198958
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 279712500
• Device Catalogue Number: 279712500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2020
• Initial Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1