MAUDE Adverse Event Report: DEPUY SPINE INC X-MESH POS INS/EXP REPL SHAFT; DRIVER, PROSTHESIS

Model Number	288900101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, the instrument was found to be broken during post-op inspection.It wasn¿t used in the surgery but was opened for the procedure.There were no patient consequences.Procedure outcome is unknown.This report involves one (1) x-mesh expandable cage system posterior inserter replacement shaft.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Part #: 288900101.Lot#: 108mi.Supplier: (b)(4) batch1: lot qty of (b)(4) units were released on november 5, 2009 no ncr's generated during production.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.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.

• Brand Name: X-MESH POS INS/EXP REPL SHAFT
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13516975
• Report Number: 1526439-2022-00207
• Device Sequence Number: 4158594
• Product Code: HWR
• UDI-Device Identifier: 10705034223049
• UDI-Public: (01)10705034223049
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• 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: 288900101
• Device Catalogue Number: 288900101
• Device Lot Number: 1108MI
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2009
• 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
• Patient Sex: Unknown