MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-17 for SUPER/RC DRBIT ARTHRO 2.9MM 211513 manufactured by Depuy Mitek Llc Us.
[118096617]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary: the complaint device was discarded by the customer therefore the device is not available for a physical evaluation. This complaint is not confirmed. It was reported that the drill bit was dull and could not go through the bone during use. No further information regarding the procedure or the device used has been provided to determine a root cause for this failure. Furthermore, no lot number was supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system. Based on the information available this complaint will be accounted for and monitored via post market surveillance activities. However, if additional information is made available, the investigation will be updated as applicable. At this point in time, no corrective action is required, and no further action is warranted. Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field. (b)(4)-incomplete. The lot number is currently unavailable. Associated medwatch: mr#1221934-2018-54512.
Patient Sequence No: 1, Text Type: N, H10
[118096618]
It was reported via phone by the sales rep that two of his super/rc drill bits were dull and would not go through the bone during a shoulder procedure. The doctor used another 2. 9 drill bit and was able to complete the procedure with no patient consequences or delays. The customer discarded both devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2018-54510 |
| MDR Report Key | 7793308 |
| Date Received | 2018-08-17 |
| Date of Report | 2018-07-27 |
| Date of Event | 2018-07-27 |
| Date Mfgr Received | 2018-07-27 |
| Date Added to Maude | 2018-08-17 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JENNIFER LAWRENCE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| Manufacturer G1 | DEPUY MITEK LLC US |
| 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 | 0 |
| Brand Name | SUPER/RC DRBIT ARTHRO 2.9MM |
| Generic Name | SURGICAL HAND DRILL |
| Product Code | GFG |
| Date Received | 2018-08-17 |
| Catalog Number | 211513 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK LLC US |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-17 |