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 2020-01-08 for SPOT 11F SUCTION TUBE 292908011 manufactured by Depuy Spine Inc.
[177167820]
(b)(4). A portion of the distal tip was broken but was not returned with the device. Additionally, a portion of the distal end is discolored/faded. No other issues were identified during inspection. A manufacturing related potential cause was not suspected, therefore, no manufacturing record evaluation is required. The complaint condition is confirmed. While no definitive root cause could be determined it is possible that the device encountered unintended forces (during usage or handling at the time of surgery). During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition. Based on the investigation findings, it has been determined that 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
[177167821]
The tip of the viper final tightener driver #286745550 got stripped during the final tightening process. The tip of the suction #292908011 is damaged. It seems that it got worn out due to repeated use along side cutting instruments. No-charge replacements needed for both. Po#2697726. Customer reference/po/service: (b)(4), was surgery delayed due to the reported event? : unknown, was procedure successfully completed? : unknown, were fragments generated? : unknown, if yes, were they removed easily without additional intervention? : unknown, patient status/ outcome / consequences: no, was other medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study --> unknown, (b)(4). Device property of: none, device in possession of: none, (b)(4). Device property of: none, device in possession of: none. By checking this box i certify that all information that are known/available has been disclosed. If any new information will be made available, the additional information will be submitted through cst. True. This complaint involves two (2) devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00277 |
| MDR Report Key | 9564915 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-08 |
| Date of Report | 2019-11-06 |
| Date of Event | 2019-11-04 |
| Date Mfgr Received | 2019-12-23 |
| Date Added to Maude | 2020-01-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 11F SUCTION TUBE |
| Generic Name | CATHETER AND TIP, SUCTION |
| Product Code | JOL |
| Date Received | 2020-01-08 |
| Returned To Mfg | 2019-12-18 |
| Catalog Number | 292908011 |
| Lot Number | ER113216 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-01-08 |