MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-12-30 for TORQUE WRENCH 277040510 manufactured by Depuy Spine Inc.
[175728508]
If the information is unknown, not available or does not apply, the section/field of the form is left blank. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a synthes employee. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. 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
[175728509]
It was reported that on an unknown date during a routine incoming inspection of a loaner set it was observed that the torque handle was found to be out of drawing specification. The drawing specification is 54-66. The torque tested low? 53. There was no known patient or hospital involvement. This report is for one torque wrench. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-52808 |
| MDR Report Key | 9530118 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-12-30 |
| Date of Report | 2019-12-02 |
| Date Mfgr Received | 2019-12-31 |
| Device Manufacturer Date | 2017-02-03 |
| Date Added to Maude | 2019-12-30 |
| 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 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TORQUE WRENCH |
| Generic Name | WRENCH |
| Product Code | HXC |
| Date Received | 2019-12-30 |
| Model Number | 277040510 |
| Catalog Number | 277040510 |
| Lot Number | KM839482 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-12-30 |