MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. 2.8MM GLENOID DRILL SHAFT; BIT, DRILL

Catalog Number DRS-0926-001

Device Problem Fracture (1260)

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

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, during a tsa surgery, doctor was using a 2.8mm glenoid drill shaft with a glenoid reamer extra small to ream the surface of the glenoid.The reamer was catching on the retractors that they had in place which broke the tip of the drill shaft that captures the reamer.Two small pieces of metal were removed from the shoulder which the surgeon confirmed were the only broken pieces of metal in the shoulder.The procedure was performed, after a non-significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation.However, the photographs were reviewed, and revealed that the tip of the drill is fractured.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: 2.8MM GLENOID DRILL SHAFT
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18395392
• MDR Text Key: 331502768
• Report Number: 3002788818-2023-00115
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00885556860236
• UDI-Public: 00885556860236
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DRS-0926-001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: RMR-0920-057-000/GLENOID REAMER EXTRA SMALL.