MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-08-19 for GII DRBIT ARTHRO 2.4MM *EA 211502 manufactured by Depuy Mitek Llc Us.
[117574781]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. The complaint device is not being returned, therefore is unavailable for a physical evaluation. Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system. Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode. At this point in time, no corrective action is required and no further action is warranted. However, 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.
Patient Sequence No: 1, Text Type: N, H10
[117574782]
It was reported by the sales rep that the customer's gii slotted drill guide was bent causing their gii artho drill bit to break at the distal tip while the surgeon tried to force the drill bit through the guide during a bicep procedure. It was confirmed nothing fell inside the patient. The surgeon used another drill guide and drill bit to complete the procedure with no patient consequences. There was a 5 minute delay. Both devices were over 2 years old and had seen a lot of use. The devices were also already discarded by the customer. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2018-51543 |
| MDR Report Key | 7796246 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-19 |
| Date of Report | 2013-10-21 |
| Date of Event | 2013-10-21 |
| Date Mfgr Received | 2018-08-20 |
| Date Added to Maude | 2018-08-19 |
| 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 | 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 | 3 |
| Brand Name | GII DRBIT ARTHRO 2.4MM *EA |
| Generic Name | SURGICAL HAND DRILL |
| Product Code | GFG |
| Date Received | 2018-08-19 |
| Catalog Number | 211502 |
| Lot Number | UNK |
| 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 MITEK LLC US |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-19 |