MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. MCP SZ. 30 PROXIMAL WW; FINGER SEMI-CONSTRAINED PYROLYTIC CARBON UNCEMENTED PROSTHESIS

Model Number	MCP10030PWW
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a mcp joint replacement surgery, the mcp sz.30 proximal ww was put in and, when the final x-rays where took, the tip of the stem was broken off.The stem was retrieved and the broken tip was drilled, a 2.7 mm screw was placed and a pair of pliers were attached to the screw and the tip was hammered out.Surgery was resumed, after a non-significant surgical delay, with a back-up 40 stem.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The product has not been received at the aus site for evaluation, but photographs were provided.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 nor 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 that medical intervention beyond the standard of care was required to address the reported event.As the device has not been received for evaluation, it could not be determined whether the device contributed to the reported event.The mcp proximal implant is an implantable device made of pyrocarbon, a material which is known to exhibit brittle overload fracture when subjected to excessive or bending forces.Intra-operative fracture is a known failure mode for the mcp implant as documented in the risk-benefit analysis for the mcp product line, rba-04-0000-0003 rev ga.1.Potential root causes include inadequate or incorrect surgical technique, such as incorrect bone preparation, and incorrect handling of the implant.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 nor 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.- clinical/medical evaluation: based on the documentation provided, the root cause of the reported event cannot be definitively concluded and a user variance could not be ruled out, even though the surgeon ¿has been using this device for years¿.The assessed patient impact was the implant fracture, extraction/upsized replacement, 0-30 minute surgical extension and modified surgical procedure.Although the surgical technique warns specifically of using metallic instrumentation for implant removal and also warns of implanting mismatched-sized components, further patient impact could not be determined.It was reported that the procedure was successfully completed using the upsized (sz 40) proximal/mc s+n backup and the patient status is ¿good¿.No further medical assessment can be rendered at this time.- visual inspection: visual examination of the part found that the mcp proximal implant stem was broken into one or more pieces.The failure was confirmed.The assessed patient impact was the implant fracture, extraction/upsized replacement, 0-30 minute surgical extension and modified surgical procedure.It was reported that the procedure was successfully completed using the upsized (sz 40) proximal/mc s+n backup and the patient status is ¿good¿.No further medical assessment can be rendered at this time.The complaint alleges that medical intervention beyond the standard of care was required to address the reported event.Additionally, a non-significant delay was reported.A visual evaluation on the returned device was performed.Visual evaluation of the returned device found that the stem tip of the implant was broken off and the reported failure was confirmed.The device was returned in two pieces, but further inspection indicated that at least one or more pieces of the broken implant was missing.The complaint detail indicates that the broken tip was drilled, a 2.7 mm screw was placed, and a pair of pliers were attached to the screw and the tip was hammered out.This would explain how the tip was fractured into additional pieces.Subsequently, damage to the fractured tip during removal hinders examination of potential defects that could have impaired the serviceability of the substrate.Therefore, a definitive root cause could not be determined.The mcp proximal implant is an implantable device made of pyrocarbon, a material which is known to exhibit brittle overload fracture when subjected to excessive or bending forces.Intra-operative fracture is a known failure mode for the mcp implant as documented in the risk-benefit analysis for the mcp product line, rba-04-0000-0003 rev ga.1.Potential root causes include inadequate or incorrect surgical technique, such as incorrect bone preparation, and incorrect handling of the implant.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 (health effect - impact code, component code, type of investigation, investigation conclusions).

• Brand Name: MCP SZ. 30 PROXIMAL WW
• Common Device Name: FINGER SEMI-CONSTRAINED PYROLYTIC CARBON UNCEMENTED PROSTHESIS
• 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: 14946834
• Report Number: 3002788818-2022-00046
• Device Sequence Number: 12111365
• Product Code: NEG
• UDI-Device Identifier: 10381780000419
• UDI-Public: 10381780000419
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P000057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,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 Expiration Date: 03/31/2025
• Device Model Number: MCP10030PWW
• Device Catalogue Number: MCP-100-30P-WW
• Device Lot Number: 211361E
• 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: 06/15/2022
• Supplement Date Received by Manufacturer: 08/26/2022; 11/02/2023
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 08/29/2022; 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female