MAUDE Adverse Event Report: SWANSON¿ FINGER JOINT IMPLANT; PROSTHESIS, FINGER, POLYMER

Model Number	G4700006
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Arthritis (1723); Pain (1994)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned at the time of this report.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient underwent a hand surgical procedure.Sometime post-op it was discovered that the metacarpophalangeal prostheses of the index finger and middle finger were broken at the prosthesis joint.This incident resulted in persistent pain and osteoarthritis for the patient.An operation had to be performed to replace the damaged prostheses with others of identical characteristics but from another laboratory.The original index finger prosthesis was implanted by the same facility however the middle finger prostheses was implanted in another hospital and was not able to be identified.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination of the devices confirms the device fractured at the proximal stem.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation the root cause is undetermined.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the patient underwent a hand surgical procedure.Sometime post-op it was discovered that the metacarpophalangeal prostheses of the index finger (d2) and middle finger (d3) were broken at the prosthesis joint.This incident resulted in persistent pain and osteoarthritis for the patient.An operation had to be performed to replace the damaged prostheses with others of identical characteristics but from another laboratory.The original index finger prosthesis was implanted by the same facility however the middle finger prostheses was implanted in another hospital and was not able to be identified.

• Brand Name: SWANSON¿ FINGER JOINT IMPLANT
• Common Device Name: PROSTHESIS, FINGER, POLYMER
• MDR Report Key: 12242622
• Report Number: 0001043534-2021-00126
• Device Sequence Number: 17266986
• Product Code: KWF
• UDI-Device Identifier: 00840420127556
• UDI-Public: 00840420127556
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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: Lay User/Patient
• Device Expiration Date: 09/16/2026
• Device Model Number: G4700006
• Device Catalogue Number: G4700006
• Device Lot Number: 1638746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2018
• 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