MAUDE Adverse Event Report: ETHICON, LLC STRATAFIX; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP2B203
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was a case of right knee arthroplasty revision, dr.[redacted] was the one who closed the first and second layer of the skin and let his pa [physician assistant] closed the rest.While closing, the pa noticed that the tip of the needle is broken.Dr.[redacted] was notified.X-ray called for broken item, charge nurse was notified also.X-ray was done and read by dr.[redacted] and the report was positive for metallic foreign body over the medial aspect of the medial femoral condyle.Dr.[redacted] open the surgical site to locate the broken needle and while doing it he is using the suction.Second x-ray was done and per radiology report the broken needle has been removed.Dr.[redacted] and dr.[redacted] also has a telephone conversation regarding the result.

• Brand Name: STRATAFIX
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON, LLC; 475 c street; los frailes industrial park, s; guaynabo PR 00969
• MDR Report Key: 25092677
• Report Number: 25092677
• Device Sequence Number: 21276547
• Product Code: NEW
• UDI-Device Identifier: 10705031465169
• UDI-Public: (01)10705031465169
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/21/2026
• Report Date (Section F): 04/21/2026

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
• Device Model Number: SXPP2B203
• Device Catalogue Number: SXPP2B203
• Device Lot Number: 107QU2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 05/06/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Date Report Sent to FDA: 04/21/2026