MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-08-06 for OSTEO-SITE BONE BIOPSY NEEDLE DBBN-13-15.0-M2-S manufactured by Cook Inc.
[116105807]
The event date was requested and it was reported that the customer does not have this information. (b)(4). This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[116105808]
It was reported that during a bone biopsy procedure, an osteo-site bone biopsy needle broke off in the bone of the patient. A section of the device did remain inside the patient? S body. It is unknown at this time if there are plans for removal. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. Additional information was requested regarding any photos, procedural imaging, and the date of the event. It has been stated that there is no further information available from the customer.
Patient Sequence No: 1, Text Type: D, B5
[125534923]
Investigation - evaluation: a review of the drawing, instructions for use (ifu) and quality control was conducted during the investigation. The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. The supplier performed a review and found no issues or gaps in quality inspection procedures. There is not enough evidence to suggest additional nonconforming devices in house or in the field. The lot number of the device is not known; accordingly, a review of the device history record could not be conducted. Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined. Manufacturing cause of failure is not suspected per supplier review. It is possible that the patients? Exceedingly hard bone may contribute to the device failing in this manner. It is also possible that user error contributed to the failure; if the device is used without the inner stylet, the outer cannula prongs may be more likely to break. Excessive force on the device once it is in place may also cause the cannula to bend and break. We have notified the appropriate personnel. We will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[125534924]
No new event description information to report at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02201 |
| MDR Report Key | 7752791 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-08-06 |
| Date of Report | 2018-10-30 |
| Date Mfgr Received | 2018-10-02 |
| Date Added to Maude | 2018-08-06 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSTEO-SITE BONE BIOPSY NEEDLE |
| Generic Name | DWO NEEDLE, BIOPSY, CARDIOVASCULAR |
| Product Code | DWO |
| Date Received | 2018-08-06 |
| Catalog Number | DBBN-13-15.0-M2-S |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-06 |