MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-02-08 for 04-1/2 EXTRACTING FORCEPS N/A 09-0516 manufactured by Biomet Microfixation.
[66828965]
Without a product return, no product evaluation is able to be conducted. 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.
Patient Sequence No: 1, Text Type: N, H10
[66828966]
It is reported that during a procedure, the instrument broke near the hinge. It is reported the pieces were recovered and no parts of the instrument were embedded in the patient. It is reported the event did not cause a delay or an injury to the patient. It is reported the procedure was completed with another available pair of forceps.
Patient Sequence No: 1, Text Type: D, B5
[68244283]
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.
Patient Sequence No: 1, Text Type: N, H10
[74382555]
The product identity was confirmed in the evaluation. Visual inspection shows moderate use. The forceps are fractured through the diameter of the hinge on one of the shanks of the forceps; therefore, the complaint is confirmed. The fracture is consistent with damage that would be caused by the impact of dropping the part. The most likely underlying cause of this complaint is general handling damage. The instructions for use for this product states in the section titled warnings and precautions: "avoid undue stress or strain when handling or cleaning instruments. " the non-conformance database was reviewed and no non-conformance was found for this product. There are no indications of manufacturing defects.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001032347-2017-00079 |
| MDR Report Key | 6312276 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-02-08 |
| Date of Report | 2017-01-11 |
| Date Mfgr Received | 2017-04-26 |
| Device Manufacturer Date | 1995-03-17 |
| Date Added to Maude | 2017-02-08 |
| 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 | DENTIST |
| 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 | 04-1/2 EXTRACTING FORCEPS |
| Generic Name | FORCEPS |
| Product Code | EMG |
| Date Received | 2017-02-08 |
| Returned To Mfg | 2017-02-09 |
| Model Number | N/A |
| Catalog Number | 09-0516 |
| Lot Number | 511322 |
| ID Number | N/A |
| Operator | DENTIST |
| 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 | 2017-02-08 |