MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-15 for PLUS SL RASPING MACHINE PLUS 75002326 manufactured by Smith & Nephew Orthopaedics Ag.
[82875514]
Patient Sequence No: 1, Text Type: N, H10
[82875515]
During surgery, the bottom came off from the rasping machine, resulting in a 2 hour delay to the procedure whilst a replacement device was located.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613369-2017-00044 |
| MDR Report Key | 6793656 |
| Date Received | 2017-08-15 |
| Date of Report | 2017-11-23 |
| Date of Event | 2017-07-28 |
| Date Mfgr Received | 2017-07-31 |
| Date Added to Maude | 2017-08-15 |
| 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 | MR. MARKUS POETTKER |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5001 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 5001 |
| Manufacturer G1 | SMITH & NEPHEW ORTHOPAEDICS AG |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5001 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 5001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PLUS SL RASPING MACHINE PLUS |
| Generic Name | RASP |
| Product Code | HTR |
| Date Received | 2017-08-15 |
| Returned To Mfg | 2017-08-14 |
| Catalog Number | 75002326 |
| Lot Number | 07088 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW ORTHOPAEDICS AG |
| Manufacturer Address | SCHACHENALLEE 29 AARAU 5001 SZ 5001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-15 |