MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-10-30 for SPOT 2MM KERRISON RONGUER, 40 292902240 manufactured by Depuy Spine Inc.
[176685841]
Product complaint # ==> b)(4). Udi: b)(4). Upon visual inspection, it is observed that there is no physical damage except normal wear which would not contribute to the reported complaint condition. It is observed that the screw that holding the assembly is rusty. The device also makes some squeaking noise when it is operated. Dimensional inspection is not required as there is no physical damage observed with the device. A visual inspection, and document/specification review were performed as part of this investigation. The complaint cannot be confirmed as no broken features were observed with the device. A definitive root cause could not be determined for the reported problem. No product design or manufacturing issues were identified, and no new malfunctions were identified either. Based upon these results, no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.
Patient Sequence No: 1, Text Type: N, H10
[179783927]
(b)(4). The 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
[179783928]
Libertas: it was reported that on (b)(6) 2019, the (1) spotlight 2mm kerrison rongeur and (1) universal navigation adaptor has failed during the calibration during reverse logistics audit of returned device at millstone. There was no patient involvement and no additional information is available. This complaint involves two (2) devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-52326 |
| MDR Report Key | 9255386 |
| Report Source | OTHER |
| Date Received | 2019-10-30 |
| Date of Report | 2019-10-07 |
| Date Mfgr Received | 2019-11-12 |
| Date Added to Maude | 2019-10-30 |
| 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 | 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 | SPOT 2MM KERRISON RONGUER, 40 |
| Generic Name | RONGEUR |
| Product Code | HTX |
| Date Received | 2019-10-30 |
| Returned To Mfg | 2019-10-11 |
| Catalog Number | 292902240 |
| Lot Number | 1108TM |
| 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 | 2019-10-30 |