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 2016-10-24 for DEAN SCISSORS SERRATED 17 CM 6- N/A 51-0990 manufactured by Biomet Microfixation.
[58209425]
It is noted that the customer shows a possible lot of 051815e15 for this item. However, the lot number could not be confirmed at this time. Because the lot number is unknown, the device history records could not be pulled and reviewed. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent. This is report one of four for the same event. Reports two through four are reported on mfr #0001032347-2016-00606 through 0001032347-2016-00608.
Patient Sequence No: 1, Text Type: N, H10
[58209426]
It is reported that this instrument fell apart during a procedure. It is reported that all parts were retrieved and there was no foreign body in the patient. It is reported that the event did not lead to a delay of more than thirty minutes.
Patient Sequence No: 1, Text Type: D, B5
[59930711]
Current information is insufficient to permit a valid conclusion about the cause of this event. A follow up report will be sent upon completion of the device evaluation. This is report one of four for the same event. Reports two through four are reported on mfr #0001032347-2016-00606 through 0001032347-2016-00608.
Patient Sequence No: 1, Text Type: N, H10
[63267871]
The product was returned for evaluation. The product identity was confirmed and the lot was identified in the evaluation. A visual inspection revealed moderate signs of wear including minor scratches and spots of discoloration. This product was found to have come completely disassembled after the blade fractured at the pin; therefore the complaint is confirmed. The most likely underlying cause was determined to be excessive applied force. According to the evaluation, there are no indications of manufacturing defects. This is report one of nine for the same event. Reports two through four, and five through nine are reported on mfr #0001032347-2016-00606-2 through 0001032347-2016-00608-2 and 0001032347-2016-00770 through 0001032347-2016-00774.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001032347-2016-00605 |
| MDR Report Key | 6051832 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-10-24 |
| Date of Report | 2016-09-27 |
| Date Mfgr Received | 2016-12-09 |
| Device Manufacturer Date | 2008-12-09 |
| Date Added to Maude | 2016-10-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MICHELLE COLE |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEAN SCISSORS SERRATED 17 CM 6- |
| Generic Name | SCISSORS |
| Product Code | EGN |
| Date Received | 2016-10-24 |
| Returned To Mfg | 2016-10-28 |
| Model Number | N/A |
| Catalog Number | 51-0990 |
| Lot Number | 120908L08 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-10-24 |