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 2017-12-07 for HEWSON SUTURE RETRIEVER 71111579 manufactured by Smith & Nephew, Inc..
[94207068]
Patient Sequence No: 1, Text Type: N, H10
[94207069]
It was reported during a surgery to repair a fractured patella the suture loop was weak and broke. There was no delay in surgery and no pieces left in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2017-01200 |
| MDR Report Key | 7097447 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-07 |
| Date of Report | 2018-03-08 |
| Date of Event | 2017-02-14 |
| Date Mfgr Received | 2017-02-20 |
| Device Manufacturer Date | 2016-04-27 |
| Date Added to Maude | 2017-12-07 |
| 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 | MARKUS POETTKER |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| 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 | HEWSON SUTURE RETRIEVER |
| Generic Name | RETENTION DEVICE, SUTURE |
| Product Code | KGS |
| Date Received | 2017-12-07 |
| Returned To Mfg | 2017-12-07 |
| Catalog Number | 71111579 |
| Lot Number | 16DSM0167 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-12-07 |