MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD ADSON TISS FCPS 4-3/4 1X2T DEL; N/A

Catalog Number	130235
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow up report will be submitted.
Event or Problem Description
The following was reported via mdr report# mw5169455: "a forcep broke during the middle of a case, the "tooth" of the instrument was unable to be found.Obtaining bilateral xrays of the knees to clear patient." there was no disclosure of patient injury, death or surgical delay.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.Additional information: b5.Additional b5 description: it was subsequently reported that the patient was under anesthesia at the time of the event.An additional device was available to complete the procedure.The event did not result in surgical delay or patient complications.It was reported that the missing piece was found during mopping of the procedure room post procedure.The adson tissue forceps 4-3/4 1x2t del (130235) was not returned to the manufacturer; therefore, an evaluation of the device could not be performed.Lot number information has been provided, manufacturing records were reviewed and no abnormalities related to the reported issue were identified.A definitive root cause could not be determined.However, the issue of breaking may be the result of wear or rough handling/environmental damage.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: ADSON TISS FCPS 4-3/4 1X2T DEL
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22071598
• Report Number: 3014334038-2025-00066
• Device Sequence Number: 8702491
• Product Code: GEN
• UDI-Device Identifier: 10381780433231
• UDI-Public: 10381780433231
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 130235
• Device Lot Number: 924028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White