MAUDE Adverse Event Report: TORNIER INC AEQUALIS PERFORM+ NEO REAMER DRIVE END; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACH

Catalog Number	MWH604
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "drive shaft snapped inside mwh604 neoreamer drive end while reaming the glenoid (both instruments from ykad264-t on consignment).Later in the operation, the surgeon found wire behind the glenoid baseplate which was removed.Surgeon asked to be advised where the wire had come from.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure.Therefore, mfr report # 0001649390-2024-00272 is to be cancelled.Furthermore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
Event or Problem Description
As reported: "drive shaft snapped inside mwh604 neoreamer drive end while reaming the glenoid (both instruments from ykad264-t on consignment).Later in the operation, the surgeon found wire behind the glenoid baseplate which was removed.Surgeon asked to be advised where the wire had come from.".

• Brand Name: AEQUALIS PERFORM+ NEO REAMER DRIVE END
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACH
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19562242
• Report Number: 0001649390-2024-00272
• Device Sequence Number: 7606478
• Product Code: HWE
• UDI-Device Identifier: 00846832070565
• UDI-Public: 00846832070565
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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 Catalogue Number: MWH604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male