MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-07-16 for SAWBLADES N/A UNKNOWN manufactured by Biomet Uk Ltd..
[16378585]
Product was returned and evaluated. The evaluation confirmed that the saw blades in the kit could only be used for a cemented procedure. The sawblades are generic and are currently being exchanged to the correct versions. This is 2 of 2 mdr reports submitted for the same event. See also: 3002806535-2013-00128.
Patient Sequence No: 1, Text Type: N, H10
[17838633]
It was reported that during a knee procedure on (b)(6) 2013, an oxford short rod instrument and the correct saw blades were missing from the loaner kit which resulted in a 30-45 minute delay in surgery. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[18247890]
The user facility is outside of the united states. No medwatch report was received. No patient injury was reported. No product has been returned. Current information is insufficient to permit a conclusion as to the cause of the event. No further complications have been reported. Manufacture date - unknown. This is 2 of 2 mdrs relating to the same reported event. Please also see mdr: 3002806535-2013-00128.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002806535-2013-00129 |
| MDR Report Key | 3229145 |
| Report Source | 01,05,06 |
| Date Received | 2013-07-16 |
| Date of Report | 2013-10-18 |
| Date of Event | 2013-06-17 |
| Date Mfgr Received | 2013-10-18 |
| Date Added to Maude | 2013-07-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. SIAN ROGERS |
| Manufacturer Street | WATERTON INDUSTRIAL ESTATES |
| Manufacturer City | BRIDGEND, SOUTH WALES CF313XA |
| Manufacturer Country | UK |
| Manufacturer Postal | CF31 3XA |
| Manufacturer Phone | 0441656655 |
| Manufacturer G1 | BIOMET UK LTD. |
| Manufacturer Street | WATERTON INDUSTRIAL ESTATES |
| Manufacturer City | BRIDGEND, SOUTH WALES CF313XA |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF31 3XA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAWBLADES |
| Generic Name | BLADE, SAW, GENERAL AND PLASTIC SURGERY |
| Product Code | DZH |
| Date Received | 2013-07-16 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET UK LTD. |
| Manufacturer Address | WATERTON INDUSTRIAL ESTATES BRIDGEND, SOUTH WALES CF313XA UK CF31 3XA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-07-16 |