MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. CENTRAL POST DRILL BIT; BIT, DRILL

Catalog Number DRL-0990-849S

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/28/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, during reverse shoulder arthroplasty, utilizing one (1) 10mm baseplate and a central post extension drill bit, the baseplate was tight going in to the glenoid and cracked the glenoid during impaction of the baseplate.The procedure was resumed , after a non-significant delay with the same device.Health status of the patient is unknown.

Event Description

It was reported that, during reverse shoulder arthroplasty, after using the central post extension drill bit, the baseplate was tight going in to the glenoid and cracked the glenoid during impaction of the baseplate.The physician suspects the tolerance/size of the drill was probably too small for the tolerance/size of the implant.The glenoid crack was supported by the screws in the baseplate.Surgery was delayed less than 30 min.Health status of the patient is unknown.

Manufacturer Narrative

H3, h6: the reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the central post drill bit.Therefore, no investigation is deemed for the other device.The device was not returned for evaluation; therefore, a device analysis could not be performed.The photographs were reviewed, and did not reveal any defects that can be attributed to the reported failure.The device shows signs of normal wear and use.The clinical/medical investigation concluded that, based on the limited information provided, the clinical root cause of the reported ¿cracked glenoid¿ cannot be definitively concluded.A procedural variance cannot be ruled out as a possible contributing factor to the reported event.Per the surgeon, ¿the tolerance/size of the drill was probably too small for the tolerance/size of the implant.¿ however, per the surgical technique supports the placement of a 10mm post extension drill bit can be used with 10-degree (fw) full wedge augmented baseplate.The surgical technique instructs on appropriate placement/preparation of impaction and implantation of the components: align the nub on the inserter with the notch in the baseplate.The nub allows rotational control while impacting.It notes that by using a post extension, a central screw cannot be used.Reportedly, the same device was used to complete the procedure and baseplate remained in place supported by the screws, after a surgical delay of less than 30 minutes.The patient impact beyond the cracked glenoid bone and potential for an early revision cannot be determined.The patient¿s current health status is unknown.No further medical assessment can be rendered.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for aetos shoulder system revealed in precautions that knowledge of surgical techniques, proper reduction, selection and placement of implants, are essential to successful outcomes.Besides, each surgeon must evaluate the appropriateness of the procedure and instruments used during the procedure.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.According with the implant and instrumentation manufacturing specification, all implants and instrumentation will be 100% visually inspected.Additionally, a review of change actions associated with the part number, was performed and there are no changes related to the device design, form, fit or function.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.No evidence on the alleged defects were found on the device, therefore no factors that can contribute to the reported event can be delineated.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.Additional information: e1 (address) corrected data: d4 (catalog number), e1 (facility name).

• Brand Name: CENTRAL POST DRILL BIT
• 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: 17764287
• MDR Text Key: 323600924
• Report Number: 3002788818-2023-00078
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00885556871348
• UDI-Public: 885556871348
• 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,Followup
• Report Date: 11/24/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DRL-0990-849S
• Device Lot Number: 22DNC0032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Male