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

Catalog Number	MWH602
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
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
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.".
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
Please note correction to d4 lot, serial no.The reported event that could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: visual inspection: the received device shows the sign of extensive usage, evident appearance of heavy scratches and marks along the distal region of the shaft.The cannulated drive shaft was broken at the level where the shaft becomes threaded and threaded portion was stuck in the drive end.The pattern of the fracture surface indicates the sign of brittle fracture.The nature of the fractured surface exhibits application of excessive rotational forces during use.Furthermore, hardness testing was done on just around the breakage point and the observed hardness is within the specification.Moreover, we cannot provide a definitive conclusion regarding the wire noted in the event as it was not returned for the investigation.However, the operative technique instructs the user to place the neo reamer assembly over a guide wire.This could be the wire in question.Without the wire being returned, we cannot conclusively determine if this is the case.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by the application excessive torsional force and rough handling of the device.However, a scope of improvement was identified and addressed by the nc to avoid the recurrence of this issue.If any further information is provided, the complaint report will be updated.

• Brand Name: AEQUALIS PERFORM+ NEO REAMER CANNULATED DRIVE SHAFT
• 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: 19561923
• Report Number: 0001649390-2024-00271
• Device Sequence Number: 7512936
• Product Code: HWE
• UDI-Device Identifier: 00846832070541
• UDI-Public: 00846832070541
• 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: MWH602
• Device Lot Number: AZ3122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/01/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• 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