MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-27 for ACUFEX ARTHROSCOPY BASKET PUNCH-DUCKLING L3203 012044 manufactured by Smith & Nephew Inc., Endoscopy Division.
[63303524]
Patient Sequence No: 1, Text Type: N, H10
[63303525]
An arthroscopic basket was being used to release the biceps tendon during surgery. When the bicep was released, the tip of the instrument broke leaving a small piece of metal within the joint. Surgeon was able to locate metal piece and safely remove it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6205125 |
| MDR Report Key | 6205125 |
| Date Received | 2016-12-27 |
| Date of Report | 2016-11-08 |
| Date of Event | 2016-11-03 |
| Report Date | 2016-11-08 |
| Date Reported to FDA | 2016-11-08 |
| Date Reported to Mfgr | 2016-11-08 |
| Date Added to Maude | 2016-12-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUFEX ARTHROSCOPY BASKET PUNCH-DUCKLING |
| Generic Name | ARTHROSCOPIC ACCESSORY |
| Product Code | KCT |
| Date Received | 2016-12-27 |
| Returned To Mfg | 2016-11-05 |
| Model Number | L3203 |
| Catalog Number | 012044 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
| Manufacturer Address | 130 FORBES BLVD. 120 FORBES BLVD. MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-27 |