MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. SILICONE PIP SZ. 2; PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Model Number SPIP-520-2-WW

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Joint Laxity (4526)

Event Date 11/28/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Event Description

It was reported that, after a surgery had been performed approximately 2/3 years ago, the patient presented with pain and instability and experienced a breakage of the silicone pip sz.1.This adverse event was solved by revision surgery on (b)(6) 2022.Current health status of patient in unknown.

Manufacturer Narrative

The product has not been returned to the aus site for evaluation and photographs were not provided, so the reported event could not be confirmed.The following investigative actions were performed.Complaint history review: the complaint history review identified similar reported events for this device.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.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: per complaint details, a revision was performed approximately 2-3 years post implantation due to pain and instability.Reportedly, ¿the implant.Had snapped.No specific event that occurred for the implants to break¿.It was communicated that the requested clinical documentation was not available.Based on the limited complaint information, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported symptoms and subsequent revision cannot be determined as the current patient status is unknown.No further medical assessment can be rendered at this time.The complaint alleges that revision surgery was required.As the device has not been returned for evaluation, it could not be determined whether the device contributed to the reported event.As the product lot number was not reported, it could not be determined whether the device met manufacturing specifications.As the device has not been returned for evaluation, a definitive root cause could not be determined.The silicone pip implant features a flexible hinge made of molded silicone.Fatigue and eventual failure of the silicone hinge is a known failure mode of the spip 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.Therefore, the most likely cause for the reported event is failure of the joint due to hinge fatigue.Other possible causes or contributing factors include trauma or improper seating resulting in additional stress on the hinge.Based on this investigation, the need for corrective action is not indicated as no non-conformances nor manufacturing 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.

Manufacturer Narrative

H3, h6: the subject device was not delivered to the address indicated; therefore, the subject device was not made available to the designated complaint unit and thus a physical product evaluation could not be performed.Additionally, photographs were not provided, so the reported event could not be confirmed.The following investigative actions were performed.Complaint history review: the complaint history review identified similar reported events for this device.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.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: per complaint details, a revision was performed approximately 2-3 years post implantation due to pain and instability.Reportedly, ¿the implants¿ had snapped¿ no specific event that occurred for the implants to break¿.It was communicated that the requested clinical documentation was not available.Based on the limited complaint information, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported symptoms and subsequent revision cannot be determined as the current patient status is unknown.No further medical assessment can be rendered at this time.The complaint alleges that revision surgery was required.As the device has not been returned for evaluation, it could not be determined whether the device contributed to the reported event.As the product lot number was not reported, it could not be determined whether the device met manufacturing specifications.As the device has not been returned for evaluation, a definitive root cause could not be determined.The silicone pip implant features a flexible hinge made of molded silicone.Fatigue and eventual failure of the silicone hinge is a known failure mode of the spip 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.Therefore, the most likely cause for the reported event is failure of the joint due to hinge fatigue.Other possible causes or contributing factors include trauma or improper seating resulting in additional stress on the hinge.Based on this investigation, the need for corrective action is not indicated as no non-conformance's nor manufacturing 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.

Manufacturer Narrative

G3: s+n was aware of this incident on 1-feb-2023.

Manufacturer Narrative

H3, h6: although a size 1 implant was originally reported by the customer, the explant received for evaluation is a size 2.The reporter was asked about the discrepancy, and they could not provide a definitive response on what the actual size of the implant was; therefore, we will investigate the size 2 implant as received.The product has been returned to the aus site for evaluation and photographs are attached, so the reported event is confirmed.The following investigative actions were performed.- complaint history review: the complaint history review identified similar reported events for this device.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.- 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: per complaint details, a revision was performed approximately 2-3 years post implantation due to pain and instability.Reportedly, ¿the implants¿ had snapped¿ no specific event that occurred for the implants to break¿.It was communicated that the requested clinical documentation was not available.Based on the limited complaint information, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported symptoms and subsequent revision cannot be determined as the current patient status is unknown.No further medical assessment can be rendered at this time.- visual evaluation: visual examination confirmed that the silicone pip implant was torn completely at the flexible hinge.The failure was confirmed.- dhr/batch record review: a dhr/batch record review could not be performed as a lot number was not provided.The complaint alleges that revision surgery was required.As the product lot number was not reported, it could not be determined whether the device met manufacturing specifications.Visual examination confirmed that the silicone pip implant was torn completely at the flexible hinge.The failure was confirmed.The silicone pip implant features a flexible hinge made of molded silicone.Fatigue and eventual failure of the silicone hinge is a known failure mode of the spip 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.Therefore, the most likely cause for the reported event is failure of the joint due to hinge fatigue.Other possible causes or contributing factors include trauma, incorrect sizing, or improper seating resulting in additional stress on the hinge.Based on this investigation, the need for corrective action is not indicated as no non-conformances nor manufacturing 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: SILICONE PIP SZ. 2
• Type of Device: 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: 16554513
• MDR Text Key: 311413156
• Report Number: 3002788818-2023-00022
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 00885556858516
• UDI-Public: 00885556858516
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K082231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/30/2023

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
• Device Operator: Health Professional
• Device Model Number: SPIP-520-2-WW
• Device Catalogue Number: SPIP-520-1-WW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 03/29/2023; 06/16/2023; 02/01/2023; 02/01/2023; 10/26/2023
• Supplement Dates FDA Received: 03/30/2023; 06/19/2023; 08/08/2023; 10/26/2023; 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention