MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. RSS GLENOSPHERE INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	HDL096006501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during reverse shoulder surgery, a glenosphere inserter broke inside the patient.The broken piece was buried in the implant and could not be retrieved.A finishing impactor was used instead to fully seat the implant.No delay was caused as a consequence of this problem.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Section h3, h6: 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.Refer to the respective tasks for further detail.Complaint history review: the complaint history review identified no similar reported events for this device or for the same product lot.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.Dhr/batch record review: identified no issues or manufacturing abnormalities which could have caused or contributed to the reported event.This review determined that the device met manufacturing specifications upon release for distribution.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 alleges no injury to the patient nor a delay during surgery.It could not be determined whether the device contributed to the reported event.The rss glenosphere inserter is a reusable instrument expected to be used across multiple surgeries.The threaded tip of the instrument is screwed into the glenosphere in order to handle the implant during insertion.The tip of the instrument could break off if excessive bending force were applied to the inserter while assembled to the glenosphere.As the instrument is reusable and used during multiple surgeries, another possible cause is wear and tear to the tip during normal use.Based on this investigation, the need for corrective action is not indicated as no non-conformances or product 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: this complaint was re-opened as the product has been received at the aus site for evaluation.The complaint was confirmed.The following investigative actions were performed.Refer to the respective tasks for further detail.- complaint history review: the complaint history review identified no similar reported events for this device or for the same product lot.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.- dhr/batch record review: identified no issues or manufacturing abnormalities which could have caused or contributed to the reported event.This review determined that the device met manufacturing specifications upon release for distribution.- 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.- visual evaluation: visual examination of the part found that the threaded tip on the reusable instrument was broken off, the reported event was confirmed.Visual evaluation of the rss glenoid inserter found that the threaded tip on the reusable instrument was broken off, the reported event was confirmed.The rss glenosphere inserter is a reusable instrument expected to be used across multiple surgeries.The threaded tip of the instrument is screwed into the glenosphere in order to handle the implant during insertion.The tip of the instrument could break off if excessive bending force were applied to the inserter while assembled to the glenosphere.As the instrument is reusable and used during multiple surgeries, another possible cause is wear and tear to the tip during normal use.Based on this investigation, the need for corrective action is not indicated as no non-conformances or product 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.H3, h6 (type of investigation, investigation findings, investigation conclusions).

• Brand Name: RSS GLENOSPHERE INSERTER
• 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: 14655116
• Report Number: 3002788818-2022-00036
• Device Sequence Number: 5109493
• Product Code: LXH
• UDI-Device Identifier: 10381780237051
• UDI-Public: 10381780237051
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HDL096006501
• Device Catalogue Number: HDL-0960-065-01
• Device Lot Number: 27242206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 07/26/2022; 11/02/2023
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 07/28/2022; 11/03/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown