MAUDE Adverse Event Report: TORNIER INC AEQUALIS¿ PERFORM REVERSED; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	MWJ111
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not returned for evaluation.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the distal part of the drill for the central screw broke off during glenoid preparation leaving a part within the patient's glenoid.
Event or Problem Description
It was reported that the distal part of the drill for the central screw broke off during glenoid preparation leaving a part within the patient's glenoid.
Additional Manufacturer Narrative
Correction: g1 manufacturing site for devices.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation.A review of the device history was not possible because the lot number was not communicated.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text: device discarded.
Event or Problem Description
It was reported that the distal part of the drill for the central screw broke off during glenoid preparation leaving a part within the patient's glenoid.

• Brand Name: AEQUALIS¿ PERFORM REVERSED
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12585236
• Report Number: 3004983210-2021-00067
• Device Sequence Number: 3421858
• Product Code: HWE
• UDI-Device Identifier: 00846832062348
• UDI-Public: 00846832062348
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 12/23/2021

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: MWJ111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 12/23/2021; 12/23/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 12/22/2021; 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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