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

Model 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	08/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (b)(4).
Event or Problem Description
It was reported that during shoulder surgery the tss head cutting template rod.2.5 broke off in the inserter.No injury or delay reported.It is unknown how this surgery finished.
Additional Manufacturer Narrative
Results of investigation: the product has not been received at the aus site for evaluation and photographs were not provided, so the complaint could not be confirmed.The following investigative actions were performed: · complaint history review: the complaint history review identified similar reported events for this device.No adverse trend was identified.Future complaints for this failure mode will continue to be monitored and investigated as required.· risk management review (device): identified no issues which could have caused or contributed to the reported event.The failure mode was previously identified by the risk management file and the anticipated risk level is acceptable.· capa/nc/pra/hhe/field action review: identified no previous events or issues which could have caused or contributed to the reported event.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.· device labeling/ifu review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met labeling requirements upon release for distribution.· product prints/specifications/procedure review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met product specifications upon release for distribution.As the device has not been received for evaluation, a definitive root cause could not be determined.The complaint indicates that there was no injury to the patient and no delay during surgery.A determination of whether the device might have contributed to the reported event could not be made as the device has not been received for evaluation.As the product lot number was not reported, a determination of whether the device met manufacturing specifications upon release for distribution could not be made.The version rod is a reusable instrument expected to be used across multiple surgeries.The threaded tip of the version rod is screwed into ports on the head of the rss reamer guide body inserter/extractor (ins-0961-049-01), then the version rod is manipulated to rotate the inserter/extractor.Potential causes for the reported instrument breakage include incorrect surgical technique and normal wear and tear.According to similar previous investigations, the rod may have been broken by inadvertently striking with the mallet due to its proximity to the striking surface.Alternatively, tensile overload applied while engaging the rod may have contributed to this failure.Finally, the failure may be the result of wear on the instrument due to normal use as the instrument is reusable.Based on this investigation, the need for corrective action is not indicated as no non-conformances or manufacturing deficiencies were identified and the risk level is acceptable.If additional information is later received, the complaint may be reopened.No further investigation is warranted for this complaint, though future complaints will be monitored and investigated as required.This investigation can be 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: 15326855
• Report Number: 3002788818-2022-00060
• Device Sequence Number: 6484426
• Product Code: LXH
• UDI-Device Identifier: 10381780247302
• UDI-Public: 10381780247302
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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
• Operator of Device: Health Professional
• Device Model Number: ROD-0923-040-001
• Device Catalogue Number: ROD-0923-040-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown