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

Catalog Number MWJ111

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

Device has not returned for evaluation.If additional information becomes available, it will be provided on a supplemental report.

Event 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 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.

Manufacturer Narrative

Correction: g1 manufacturing site for devices.

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 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
• Type of Device: 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
• MDR Text Key: 281129982
• Report Number: 3004983210-2021-00067
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00846832062348
• UDI-Public: 00846832062348
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MWJ111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1