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 2017-08-14 for HALO VEST AF101W manufactured by Depuy-synthes Spine.
[83133852]
Unknown gtin, incomplete lot # provided, udi is unavailable. A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the 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
[83133853]
On (b)(6) 2017, the surgery was performed using the bremer halo vest system. During the surgery, the backward belt of bremer air-flo vest short (part#:af101w, lot#: 06229) got broken. The surgeon heard the broken part snap when he was tightening the screw, and then the handle was separated from the screw. The surgery was successfully completed without any delay, and there was no adverse consequence to the patient.
Patient Sequence No: 1, Text Type: D, B5
[120146485]
Visual examination of the returned device found the screw on the back of the vest was broken. A review of the device history record was conducted. No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer. A trend analysis was conducted. No emerging trends were found requiring further actions. The root cause of the screw breaking cannot be determined from the samples and the information provided. A potential root cause may be an unexpectedly high amount of torque being placed on the screw, resulting in the bond between the screw cap and screw shank failing. As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file 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
| Report Number | 1526439-2017-10659 |
| MDR Report Key | 6792695 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-14 |
| Date of Report | 2017-07-20 |
| Date of Event | 2017-07-20 |
| Date Mfgr Received | 2017-10-23 |
| Device Manufacturer Date | 2017-03-06 |
| Date Added to Maude | 2017-08-14 |
| 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 |
| 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 | 5088808201 |
| Manufacturer G1 | DEPUY-SYNTHES SPINE |
| 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 | HALO VEST |
| Generic Name | ORTHOSIS, CERVICA |
| Product Code | IQK |
| Date Received | 2017-08-14 |
| Returned To Mfg | 2017-10-02 |
| Catalog Number | AF101W |
| Lot Number | 062295 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY-SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-14 |