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

Catalog Number	INS096009401
Medical Device Problem Codes	Fracture (1260); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a titan shoulder surgery, one (1) rss humeral body inserter/extractor knob broke off inside one (1) rss humeral body inserter / extractor and one (1) reamer guide body inserter/ extractor mod.The body could not be separated from the inserter.Nothing fell into patient.The procedure was resumed, without any delay, using the same devices.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H11: three devices were reported and only one was entirely returned and evaluated.The visual inspection revealed that the extractor returned with two of the slots blocked by unidentifiable fractured devices.The returned device is worn from heavy use.For the knob, device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.For the body and the mod, a review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the knob, a review of complaint history of the previous 12 months revealed similar events for the listed part number, this failure mode will be monitored for future complaints for any necessary corrective actions.For the body, a review of complaint history revealed similar events for the listed part number 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.For the mod, 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 risk management files revealed these failure modes were previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this products and events.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.These devices are reusable instruments 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: 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 24259957
• Report Number: 3002788818-2026-00015
• Device Sequence Number: 9550115
• Product Code: LXH
• UDI-Device Identifier: 00885556863992
• UDI-Public: 885556863992
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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 Catalogue Number: INS096009401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/27/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown