MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS¿ PERFORM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	MWE413
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
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
It was reported that the m40 cortiloc trial broke off inside the patient.The physician placed a threaded guide wire into the piece to pull it out of the patients glenoid.It was successfully removed.No patient impact was reported.
Additional Manufacturer Narrative
Correction - d9 (returned to manufacturer on).The reported event could be confirmed since the device was returned for evaluation matches the alleged failure.The device inspection revealed the following: the received device shows signs of extensive usage & application of high external forces leading the complete breakage in one of the three pegs.The grasping area is highly deformed with grasper marks observed and the material is scratched/gouged at the surface of the device.All the device surfaces reveal improper usage.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by abnormal usage of the device.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the m40 cortiloc trial broke off inside the patient.The physician placed a threaded guide wire into the piece to pull it out of the patients glenoid.It was successfully removed.No patient impact was reported.

• Brand Name: AEQUALIS¿ PERFORM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13938596
• Report Number: 3000931034-2022-00150
• Device Sequence Number: 14583664
• Product Code: LXH
• UDI-Device Identifier: 03700386974441
• UDI-Public: 03700386974441
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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: MWE413
• Device Lot Number: 17B565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2017
• 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: Unknown