MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC AEQUALIS¿ PERFORM REVERSED; BIT, SURGICAL

Catalog Number MWJ127

Device Problems Break (1069); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2022

Event Type  malfunction  

Manufacturer Narrative

Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Event Description

The tip of the screw driver broke off inside the screw head during final tightening of the set screw.The tip remained inside the screw head of the implant and it took the surgeon a minimal amount of time (estimated 3-4 minutes) to remove the broken off portion of the instrument.It was successfully removed with no impact to the patient.

Event Description

The tip of the screw driver broke off inside the screw head during final tightening of the set screw.The tip remained inside the screw head of the implant and it took the surgeon a minimal amount of time (estimated 3-4 minutes) to remove the broken off portion of the instrument.It was successfully removed with no impact to the patient.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation.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.If the device is returned or any further information is provided, the complaint report will be updated.H3 other text: device not returned.

• Brand Name: AEQUALIS¿ PERFORM REVERSED
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 13559112
• MDR Text Key: 290465197
• Report Number: 3004983210-2022-00016
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 00846832062492
• UDI-Public: 00846832062492
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 03/29/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: MWJ127
• Device Lot Number: CR0118346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 03/02/2022
• Supplement Dates FDA Received: 03/29/2022
• 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