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 2019-04-30 for 2.0MM DRILL BIT W/DEPTH MARK QC/110MM 310.534 manufactured by Oberdorf Synthes Produktions Gmbh.
[143569539]
Device is expected to be returned for manufacturer review/investigation, but has not been received yet. Product was not returned. Based on the information available, it has been determined that no corrective and 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
[143569540]
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, the patient underwent a peroneal transdermal fracture surgery. During the surgery, the tip of the drill bit broke and was left inside the patient. It is unknown if there was a surgical delay. The procedure outcome is unknown. The patient status was okay with no complications on the surgery. This report is for one (1) drill bit. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-63272 |
| MDR Report Key | 8565253 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-01 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-09-16 |
| Device Manufacturer Date | 2013-08-08 |
| Date Added to Maude | 2019-04-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | WERK BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2.0MM DRILL BIT W/DEPTH MARK QC/110MM |
| Generic Name | BIT MILLING STERILE AND NON |
| Product Code | GFG |
| Date Received | 2019-04-30 |
| Returned To Mfg | 2019-08-16 |
| Catalog Number | 310.534 |
| Lot Number | 8563518 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-30 |