MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-02 for R3 STRAIGHT SHELL IMPACTOR 71364450 manufactured by Smith & Nephew, Inc..
[181583536]
It was reported that during surgery, weld on r3 straight shell impactor threads broke while inside the patient. All pieces were removed. Length of delay unknown. Smith and nephew backup device available and no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-00742 |
| MDR Report Key | 9773956 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2016-11-22 |
| Date Added to Maude | 2020-03-02 |
| 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 |
| 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 City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 0447940038 |
| 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 | R3 STRAIGHT SHELL IMPACTOR |
| Generic Name | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
| Product Code | MDM |
| Date Received | 2020-03-02 |
| Model Number | 71364450 |
| Catalog Number | 71364450 |
| Lot Number | 16HSA0051 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-02 |