FDA Adverse Event
Injury
Summary report: N
SAIPH
MDR report key: 23414092
·
Received October 29, 2025
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Report
- Report Number
- 3016096064-2025-00002
- Event Type
- Injury
- Date Received
- October 29, 2025
- Date of Event
- October 23, 2025
- Report Date
- October 29, 2025
- Manufacturer
- MATORTHO LTD
- Product Code
- HWA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
DATE OF ACTUAL SURGERY NOT KNOWN, INFORMATION RECEIVED VIA WHATSAPP ON 23-OCT. (B)(6) IS ON LEAVE UNTIL MONDAY AND WILL PROVIDE FURTHER DETAILS THEN. I HAVE ADVISED (B)(6) A PER IS REQUIRED. "HI (B)(6), WE HAVE AN ISSUE IN (B)(6) HOSPITAL. THE TIP (3 MM METAL) OF THE BEARING IMPACTOR SAIPH BROKE AND ENDED UP IN THE PATIENT UNNOTICED. THIS REQUIRES A SMALL RE OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224490 | SAIPH | SAIPH BEARING IMPACTOR | HWA | MATORTHO LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |