MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. SILICONE MCP SZ 20; PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Catalog Number	SMCP-500-20-WW
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).(b)(4).This reports covers the failure of the silicone pip sz.0 that was implanted in the ring finger.(b)(4).This reports covers the failure of the silicone mcp.0 that was implanted in the middle finger.(b)(4).This reports covers the failure of the silicone mcp.0 that was implanted in the index finger.
Event or Problem Description
It was reported that, after a trauma surgery had been performed on (b)(6) 2022, one year later one (1) silicone pip sz and two (2) unkn mcp impl broke.A revision surgery was performed on (b)(6) 2023 to address this adverse event.Current health status of patient is good.The primary silicone pip sz.0 was implanted in the ring finger, and the silicone mcp products were implanted in the middle and index finger.This reports covers the failure of the silicone mcp.0 that was implanted in the index finger.
Additional Manufacturer Narrative
B5: describe event or problem, d10: device available for evaluation? and h6: medical device problem code.Section h3, h6: the associated device was returned and evaluated.Visual examination confirmed that the silicone mcp implant was completely torn and in multiple pieces.The device was in 3 separate pieces with a tear at the hinge and just below the hinge.Additionally, the implant was significantly damaged with tears and nicks all over the device.It cannot visually be determined whether the noted damage is from wear or removal of the implant.The clinical/medical investigation concluded that, per complaint details, a revision was performed approximately 1 year post implantation due to the silicone pip (ring finger) and mcp (middle and index finger) implant breakages in the left hand.Reportedly, the patient current health status is good; however, it was communicated that the requested clinical documentation was not available.Reportedly, the revision was due to the implant breakages.The patient impact included the reported silicone pip and mcp implant breakages and the revision, but due to the limited information, no further assessment can be rendered.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¿ silicone mcp & pip revealed in warnings that excessive activity of the affected joint, uncorrected or recurrent deformity, incorrect sizing of the implant, inadequate soft tissue or bony support and/or implant malposition may damage the structural integrity of the device.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.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Potential root causes or contributing factors include failure of the joint due to hinge fatigue, trauma, incorrect sizing, or improper seating resulting in additional stress on the hinge/implant.The silicone mcp implant features a flexible hinge made of molded silicone.Fatigue and eventual failure of the silicone hinge is a known failure mode of the mcp device.To mitigate this risk, the hinge is molded to rest at a pre-flexed angle which results in less strain on the implant and can extend fatigue life.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.D1: brand name, d4:catalog #, lot #, expiration date and unique identifier (udi) # h6: medical device problem code.
Event or Problem Description
It was reported that, after a trauma surgery had been performed on (b)(6) 2022, one year later one (1) silicone pip sz and two (2) silicone mcp sz 20 broke.A revision surgery was performed on (b)(6) 2023 to address this adverse event.Current health status of patient is good.The primary silicone pip sz.0 was implanted in the ring finger, and the silicone mcp products were implanted in the middle and index finger.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.Visual examination confirmed that the silicone mcp implant was completely torn and in multiple pieces.The device was in 3 separate pieces with a tear at the hinge and just below the hinge.Additionally, the implant was significantly damaged with tears and nicks all over the device.It cannot visually be determined whether the noted damage is from wear or removal of the implant.The clinical/medical investigation concluded that, per complaint details, a revision was performed approximately 1 year post implantation due to the silicone pip (ring finger) and mcp (middle and index finger) implant breakages in the left hand.Reportedly, the patient current health status is good; however, it was communicated that the requested clinical documentation was not available.Reportedly, the revision was due to the implant breakages.The patient impact included the reported silicone pip and mcp implant breakages and the revision, but due to the limited information, no further assessment can be rendered.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 revealed a similar event for the listed device 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.A review of the instructions for use documents for ascension¿ silicone mcp & pip revealed in warnings that excessive activity of the affected joint, uncorrected or recurrent deformity, incorrect sizing of the implant, inadequate soft tissue or bony support and/or implant malposition may damage the structural integrity of the device.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.Potential root causes or contributing factors include failure of the joint due to hinge fatigue, trauma, incorrect sizing, or improper seating resulting in additional stress on the hinge/implant.The silicone mcp implant features a flexible hinge made of molded silicone.Fatigue and eventual failure of the silicone hinge is a known failure mode of the mcp device.To mitigate this risk, the hinge is molded to rest at a pre-flexed angle which results in less strain on the implant and can extend fatigue life.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: SILICONE MCP SZ 20
• Common Device Name: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• 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: 18132772
• Report Number: 3002788818-2023-00102
• Device Sequence Number: 15348697
• Product Code: KYJ
• UDI-Device Identifier: 00885556856895
• UDI-Public: 885556856895
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K082231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2024

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: 03/31/2024
• Device Catalogue Number: SMCP-500-20-WW
• Device Lot Number: 211246E
• 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: 10/24/2023
• Supplement Date Received by Manufacturer: 02/09/2024; 10/02/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 02/12/2024; 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2020
• 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: Female