MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-23 for TORQUE WRENCH 277040510 manufactured by Depuy Spine Inc.
[176648011]
If the information is unknown, not available or does not apply, the section/field of the form is left blank. Reporter is a company representative. A review of the receiving inspection (ri) for torque wrench was conducted identifying that lot number bv651549 was released in two batches. Batch1: was released on september 12, 2011 with no discrepancies. Batch2: was released on september 24, 2013 with no discrepancies. As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer. Visual inspection: the torque wrench was received at us customer quality (cq). There were light surface scratches on the handle and knob of the device. The pin that connects the torque handle to the knob appears bent. Functional test: turning the knob clockwise/counter-clockwise was not possible as the knob was jammed. The knob cannot be turned to either the 60 in-lb or 100in-lb setting. Because the knob was jammed, the overall complaint was confirmed as the torque wrench does not function appropriately. Dimensional inspection: a dimensional inspection was not performed as the internal components were inaccessible without destruction of the device. Document/specification review: drawing(s) reviewed: current & manufactured revisions conclusion: the overall complaint was confirmed for the received torque wrench as the knob to change settings was jammed. Although no definitive root-cause can be determined, it? S possible the device experienced unintended forces which lead to an internal mechanical failure. There was no indication that a design or manufacturing issue contributed to the complaint. No design issues were observed during the document/specification review. 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. 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
[176648012]
It was reported that during routine incoming inspection of a loaner set on an unknown date, it was observed that the torque handle was non-functional. The product has been quarantined and is available and is being returned. There was no patient involvement. Upon manufacturer receipt and investigation, it was determined that the device was jammed/seized. This report is for a torque wrench. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00445 |
| MDR Report Key | 9623642 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-23 |
| Date of Report | 2019-11-26 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2011-09-12 |
| Date Added to Maude | 2020-01-23 |
| 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 | 2020-01-23 |
| Returned To Mfg | 2019-12-13 |
| Model Number | 277040510 |
| Catalog Number | 277040510 |
| Lot Number | BV651549 |
| 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 | 2020-01-23 |