MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-23 for 3.5MM LOCKING HEX T-HANDLE 74016422 manufactured by Smith & Nephew, Inc..
[176092246]
It was reported that during surgery when the surgeon impacted the t handle with a mallet the tip broke. It is unknown if all pieces were retrieved from the patient. Attempts were made to retrieve further information but no response was received from the complainant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-00368 |
| MDR Report Key | 9622152 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-23 |
| Date of Report | 2020-01-23 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-01-06 |
| Date Added to Maude | 2020-01-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. SARAH FREESTONE |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.5MM LOCKING HEX T-HANDLE |
| Generic Name | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
| Product Code | MDM |
| Date Received | 2020-01-23 |
| Returned To Mfg | 2020-01-12 |
| Catalog Number | 74016422 |
| Lot Number | 18JSC0012 |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-23 |