MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-01 for UNKNOWN EXTRACTION INSTRUMENTS manufactured by Depuy Spine Inc.
[127538936]
(b)(4). The unknown extraction instruments was not returned to the customer quality unit for evaluation. It was noted that the device was discarded. However, image of the device was provided to the customer quality unit. It was noted that the tube had fractured at a point where the tube reduces in diameter. A device history record review could not be conducted as a lot number was not available. All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting. Without the return of the unknown extraction instruments we are unable to identify the root cause. As no issues could be identified in the manufacturing or release of this product since the lot number could not be identified. Therefore, this complaint will be closed with no further action required. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[127538937]
It was reported that during the first use of the product the surgeon was using the device inside the disc to scrape and remove disc material when he levered the tube to move to a different position at which point the tube snapped at the point where it reduces in diameter. The device stayed as one piece and was removed from the disc and discarded. The surgeon mentioned that he was moving the device when it broke with side pressure being applied to the tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2018-51038 |
| MDR Report Key | 8030503 |
| Date Received | 2018-11-01 |
| Date of Report | 2018-10-18 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2018-10-18 |
| Date Added to Maude | 2018-11-01 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASON BUSCH |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| Manufacturer G1 | DEPUY SPINE INC |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN EXTRACTION INSTRUMENTS |
| Generic Name | UNKNOWN |
| Product Code | HAO |
| Date Received | 2018-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SPINE INC |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-01 |