FDA Adverse Event
Malfunction
Summary report: N
NA
MDR report key: 18605759
·
Received January 30, 2024
Report
- Report Number
- 18605759
- Event Type
- Malfunction
- Date Received
- January 30, 2024
- Date of Event
- December 20, 2023
- Report Date
- December 29, 2023
- Manufacturer
- SMITH NEPHEW INC.
- Product Code
- HAB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DR. [REDACTED NAME] WAS USING THE SN ARTHROSCOPIC 3.5 CURVED SHAVER TIP, SOMETHING HE USES FOR 90% OF HIS CASES, AND THE TIP STOPPED OSCILLATING. WHEN THEY TOOK THE SHAVER APART, IT WAS NOTED THAT THE INSIDE PIECE BROKE APART. NOTHING WAS LEFT INSIDE THE PATIENT; ALL PIECES WERE STILL INSIDE THE SHAVER SHEATH. PACKAGING WAS FOUND: REF: 7210980, LOT#: 51169563. REPS WERE NOTIFIED, ONE OF THE SHAVER TIPS WAS SET ASIDE AND IS AT THE [REDACTED NAME] CONTROL DESK. MANUFACTURER RESPONSE FOR ARTHROSCOPIC 3.5 CURVED SHAVER TIP, (BRAND NOT PROVIDED) (PER SITE REPORTER). CLINICAL SITE NOTIFIED MANUFACTURER REP DIRECTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2546060 | NA | SAW, POWERED, AND ACCESSORIES | HAB | SMITH NEPHEW INC. | 7210980 | 51169563 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |