MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-06-14 for BALL TIP FEELER STRAIGHT 275010140 manufactured by Depuy Spine Inc.
[148062016]
(b)(4). Device is available for evaluation. Investigation will be conducted. Follow up will be filed with the investigation results. 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
[148062017]
It was reported that on (b)(6) 2019, during an unknown procedure the tip of the screwdriver was found twisted before being use. Probably it got twisted due to repeated use since it was a consignment item. Another instrument was used and the tip of the probe broke. It was bent after being used and upon trying to straighten it out a small piece broke off. This was done on the side table and nothing went in the patient, the small fragment was discarded. It is unknown if there was no surgical delay. Patient status is unknown. This complaint involves two (2) device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-51762 |
| MDR Report Key | 8700149 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-06-14 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-05-22 |
| Date Mfgr Received | 2019-08-12 |
| Device Manufacturer Date | 2012-10-02 |
| Date Added to Maude | 2019-06-14 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| 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 | 3 |
| Brand Name | BALL TIP FEELER STRAIGHT |
| Generic Name | PROBE |
| Product Code | HXB |
| Date Received | 2019-06-14 |
| Returned To Mfg | 2019-06-18 |
| Model Number | 275010140 |
| Catalog Number | 275010140 |
| Lot Number | TY16842 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-06-14 |