MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	INS096009401
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number: (b)(6).Initial mdr report.
Event or Problem Description
It was reported that, during surgery, a tss head cutting template rod.2.5 fractured off as it was accidentally hit while malleting out the inserter/extractor, leaving a broken piece of the handle inside the inserter/extractor.That piece could not be removed.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
The product has not been returned to the aus site for evaluation and photographs were not provided, so the reported event 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.The product was not received at the aus site for evaluation and photographs were not provided, so the complaint could not be confirmed.The complaint alleges no injury to the patient nor a delay during surgery.As the part was not returned for evaluation, a determination of whether the device contributed to the reported event could not be made.As the product lot number was not reported, a determination of whether the device met manufacturing specifications could not be made.The rss humeral body inserter/extractor knob is a reusable instrument expected to be used across multiple surgeries.The threaded tip of the knob is screwed into a port on the humeral body inserter/extractor instrument to secure the humeral body to the instrument for insertion and extraction.The tip of the knob may be subjected to significant loading, tension, and bending forces during impaction or while the assembled instruments are manipulated.Previous similar investigations identified tensile overload applied to the knob during use as a potential cause for breakage of the instrument.Therefore, the most probable causes for the reported event are tensile overload and/or wear due to normal use.Based on this investigation, the need for corrective action is not indicated as no non-conformances nor 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.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed that the threaded tip on the reusable instrument was broken off, the reported event was confirmed.Visual evaluation identified signs of wear from normal use but could not determine a definitive root cause.The rss humeral body inserter/extractor knob is a reusable instrument expected to be used across multiple surgeries.The threaded tip of the device is screwed into a port on the humeral body inserter/extractor instrument to secure the humeral body to the instrument for insertion and extraction.It is likely that the device contributed to the event from wear due to normal use.According to risk documentation for the rss system, probable causes for instrument breakage or damage include inadequate design, inadequate or incorrect surgical technique, and normal wear.Previous similar investigations identified tensile overload applied to the knob when attempts were made to screw or unscrew the body from the inserter/extractor as a potential cause for breakage and damage to the instrument.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 revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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.Additionally, part must be in compliance with the implant and instrumentation manufacturing specification.Furthermore, critical dimensions of the device must be verified with an integra approved inspection method.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.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: RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB
• 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: 16368119
• Report Number: 3002788818-2023-00012
• Device Sequence Number: 17956723
• Product Code: LXH
• UDI-Device Identifier: 10381780527022
• UDI-Public: 10381780527022
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Followup
• Report Date (Section B): 11/08/2023

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: INS096009401
• Device Catalogue Number: INS096009401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 03/14/2023; 11/07/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 03/17/2023; 11/08/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INS-0961-048-01
• Patient Sex: Unknown