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 2020-03-31 for ARTICULAR SURFACE PROVISIONAL SZ 4 8MM 00584102408 manufactured by Smith & Nephew, Inc..
[185721334]
It was reported that during surgery, insert trial broke. All pieces were recovered from the patient. No harm to patient or staff. No substantial procedural delay. No back up available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-01084 |
| MDR Report Key | 9902599 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-31 |
| 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 | ARTICULAR SURFACE PROVISIONAL SZ 4 8MM |
| Generic Name | TEMPLATE |
| Product Code | HWT |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-10 |
| Catalog Number | 00584102408 |
| Lot Number | 60998042 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-31 |