MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. TSS HEAD CUTTING TEMPLATE ROD. 2.5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	ROD-0923-040-001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint number: (b)(4).
Event or Problem Description
It was reported that, during tsa surgery, one (1) tss head cutting template rod.2.5; one (1) rss humeral body inserter / extractor and one (1) combo inserter/impactor.M were broke during the case.No x-rays available, items were not broken inside patient and no pieces were left in patient.The procedure was resumed, after a non-significant delay, with the same devices.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
H10: after further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that one (1) tss head cutting template rod.2.5.Broke during the case.However, after further clarification and information received, it was determined that the issue does not meet the criteria to be reportable.The threaded tip of the tss head cutting template rod.2.5 broke off and stuck in the left 30-degree notch of the rss humeral body inserter / extractor.Moreover, if the device malfunction were to recur, it would not be likely to cause or contribute to a death or serious injury.While this event is no longer considered reportable, this report is being submitted as a courtesy to provide updated investigation results based on the return and evaluation of the complaint device subsequent to the submission of our previous report.The associated device was returned and evaluated.The visual inspection revealed that the threaded tip of the tss head cutting template rod.2.5 was broken off.Visual evaluation identified a clean break at the threaded tip, but a definitive root cause could not be made.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 based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.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 evidence to conclude 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 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: TSS HEAD CUTTING TEMPLATE ROD. 2.5
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 18490763
• Report Number: 3002788818-2024-00003
• Device Sequence Number: 19755667
• Product Code: LXH
• UDI-Device Identifier: 00885556861912
• UDI-Public: 00885556861912
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

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 Catalogue Number: ROD-0923-040-001
• Device Lot Number: 259885-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown