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 2020-03-24 for EXPEDIUM SPINE SYSTEM BALL TIP FEELER (STRAIGHT) 10-100MM 299704125 manufactured by Depuy Spine Inc.
[185613389]
The complaint device was not received for investigation. The image(s) were reviewed and the complaint condition could be confirmed. It was noticed that the ball tip feeler shaft is separated from the handle, the failure occurred at the weld connection between the tip and the handle. Since the device was not returned, a dimensional inspection and a functional test were not able to be performed. A definitive assignable root cause could not be determined based on the provided information. During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Device history lot a review of the receiving inspection (ri) for ball tip feeler, st was conducted identifying that lot number pu109649 was released in a single batch. Batch units were released on 12 aug 2016 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. The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer. 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
[185613390]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the pedicle feeler unexpectedly disassembled during a routine cleaning operation. No further information provided. This report is for one (1) expedium spine system ball tip feeler (straight) 10-100mm plus or minus 4 percent. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00751 |
| MDR Report Key | 9872032 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-24 |
| 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 | EXPEDIUM SPINE SYSTEM BALL TIP FEELER (STRAIGHT) 10-100MM |
| Generic Name | PROBE |
| Product Code | HXB |
| Date Received | 2020-03-24 |
| Model Number | 299704125 |
| Catalog Number | 299704125 |
| Lot Number | PU109649 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-24 |