MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. RSS GLENOID BASEPLATE IMPACTOR-S; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	IMP-0961-064-S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a reverse total shoulder surgery, the tip of a rss glenoid baseplate impactor-s is broken off.No pieces felt inside patient.The procedure was completed, without delay, using the same device.Patient was not harmed.
Additional Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
Additional Manufacturer Narrative
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 similar reported events for this device.No previous events or issues were identified 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 was determined that the device likely contributed to the reported event as the most probable cause of the failure was wear and damage due to normal use.The rss glenoid baseplate impactor is a reusable instrument expected to be used across multiple surgeries.Further, its intended use is to absorb forces exerted on the glenoid baseplate, an implantable component of the reverse shoulder system, during impaction in order to prevent damage to the implant.Therefore, the plastic tip of the device may fail after prolonged use or if subjected to excessive force, such as during impaction.This probable cause is supported by similar previous complaints.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 similar reported events for this device.No previous events or issues were identified 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 evaluation of the rss glenoid baseplate impactor found that the distal tip on the reusable instrument was broken off, the reported event was confirmed.The complaint alleges no injury to the patient nor a delay during surgery.It was determined that the device likely contributed to the reported event as the most probable cause of the failure was wear and damage due to normal use.Visual evaluation of the rss glenoid baseplate impactor found that the distal tip on the reusable instrument was broken off, the reported event was confirmed.The rss glenoid baseplate impactor is a reusable instrument expected to be used across multiple surgeries.Further, its intended use is to absorb forces exerted on the glenoid baseplate, an implantable component of the reverse shoulder system, during impaction in order to prevent damage to the implant.The tip of the rss glenoid baseplate impactor is made with radel, a durable plastic material.Therefore, the plastic tip of the device may fail after prolonged use or if subjected to excessive force, such as during impaction.Based on visual evaluation, and nature of the device, the most probable cause for the reported event is wear due to normal use.This probable cause is supported by similar previous complaints.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.

• Brand Name: RSS GLENOID BASEPLATE IMPACTOR-S
• 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 ; 11101 metric blvd; austin, TX 78758 ; 5123913905
• MDR Report Key: 14366189
• Report Number: 3002788818-2022-00009
• Device Sequence Number: 5782773
• Product Code: LXH
• UDI-Device Identifier: 10381780467786
• UDI-Public: 10381780467786
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IMP-0961-064-S
• Device Catalogue Number: IMP-0961-064-S
• Device Lot Number: 26384502
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 05/27/2022; 11/02/2023
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 05/30/2022; 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown