| Brand Name | CHONDRO PICK, CONVEX, 60 DEGREE TIP |
| Common Device Name | MANUAL INSTR, GENERAL SURGICAL |
| Manufacturer (Section D) |
| ARTHREX, INC. |
| 1370 creekside boulevard |
| naples FL 34108 1945 |
|
| Manufacturer (Section G) |
| ARTHREX, INC. |
| 1370 creekside boulevard |
|
| naples FL 34108 1945 |
|
| Manufacturer Contact |
|
| MDR Report Key | 25068729 |
| Report Number | 1220246-2026-02656 |
| Device Sequence Number | 18746613 |
| Product Code |
MDM
|
| UDI-Device Identifier | 00888867044654 |
| UDI-Public | (01)00888867044654(10)12122801 |
| Combination Product (Y/N) | N |
| Initial Reporter Country | GM |
| PMA/510(K) Number | EXEMPT |
| Number of Events Summarized | 1 |
| Summary Report (Y/N) | N |
| Reporter Type |
Manufacturer
|
| Report Source |
Foreign,Distributor |
| Initial Reporter Occupation |
Administrator/Supervisor
|
| Type of Report
| Initial,Followup |
| Report Date (Section B) |
07/01/2026 |
| 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
|
| Operator of Device |
Health Professional
|
| Device Model Number | CHONDRO PICK, CONVEX, 60 DEGREE TIP |
| Device Catalogue Number | AR-8672 |
| Device Lot Number | 12122801 |
| Was Device Available for Evaluation? |
Yes
|
| Type of Report(Section G) | Thirty-Day |
| Initial Date Received by Manufacturer | 04/17/2026 |
| Supplement Date Received by Manufacturer | 06/23/2026
|
| Initial Report FDA Received Date | 05/04/2026 |
| Supplement Report FDA Received Date | 07/01/2026
|
| Was Device Evaluated by Manufacturer? (Y/N) |
Yes
|
| 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 |
Reuse
|
| Patient Sequence Number | 1 |
| Patient Sex | Unknown |
|
|