MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. MCP SZ. 10 PROXIMAL WW; FINGER SEMI-CONSTRAINED PYROLYTIC CARBON UNCEMENTED PROSTHESIS

Catalog Number	MCP-100-10P-WW
Medical Device Problem Codes	Fracture (1260); Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a mcp joint replacement surgery, after impacting the proximal component of the mcp sz.10 proximal ww, it was found to have rotated in the canal.Surgeon decided to remove and reposition the implant.Upon using the mcp implant extractor tool and pulling the implant out by wrapping fibretape around the top of the stem, the implant stem broke in two, leaving the tip of the stem inside the canal.The broken implant was removed by loosening with k-wires and saline wash.The procedure was resumed, after a non-significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.No pictures nor x-rays available.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the information provided, a procedure/surgical technique cannot be ruled out as a possible contributing factor to the reported stem fracture.However, since the canal reportedly underwent a saline wash with k-wire assist to remove the tip, there is little risk of residual particulate debris from the broken pyrocarbon implant.The patient impact included the implant breakage upon first attempt to remove/reposition the implant, the required interventions to remove the tip from the canal, use of a backup device and the 0-30 minute surgical delay.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 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 instructions for use documents for ascension mcp metacarpophalangeal joint implant revealed that potential adverse effects associated with total joint prostheses and surgery include implant fracture.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.According with the implant and instrumentation manufacturing specification, all implants and instrumentation will be 100% visually inspected.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, surgical technique, patient anatomy and/or excessive forces.Based on this investigation, the need for corrective action is not indicated.Should the device or 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.H10 ¿ additional information d6a / d6b / d7a ¿ implanted/explanted date h11 - corrected data e1- initial reporter name g2- report source.

• Brand Name: MCP SZ. 10 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: 18171953
• Report Number: 3002788818-2023-00108
• Device Sequence Number: 7653215
• Product Code: NEG
• UDI-Device Identifier: 00885556856727
• UDI-Public: 00885556856727
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P000057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2024

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: 07/31/2024
• Device Catalogue Number: MCP-100-10P-WW
• Device Lot Number: 202730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 12/18/2023; 08/20/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 12/22/2023; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown