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 2018-09-04 for PRESSFT DRILL BIT, 2.1MM, HIP NDB21H manufactured by Conmed Corporation.
[119112177]
Visual examination of the returned, used device confirmed the reported problem and found the device broken off at the tip. The broken tip is approximately 0. 500 of an inch and was not returned for evaluation. Without the return of the machined drill tip, examination is not able to identify any issues with the machining process. No discrepancies with the dimension or the straightness of the drill were found. The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product. The product released for distribution was found to have met all specifications prior to shipment. This is the only complaint for this lot number and failure mode within the past two years. A two-year review of complaint history revealed there has been a total of one complaint, regarding this one device, for this device family and failure mode. During this same time frame (b)(4) devices have been manufactured and shipped worldwide. Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4). Per the instructions for use, the user is advised the following: precautions: inspect instrument prior to use to ensure it is in good physical condition and functions properly. There should be no loose, broken or misaligned parts. Exercise care in the use of the device to minimize side or bending loads. Do not use excessive force on instruments to avoid damage or breakage during use. Avoid unintended contact with other surgical instruments during use to prevent damage or breakage. Inspect instrument after use to ensure it has not been damaged. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[119112178]
The sales representative reported on behalf of the customer that the ndb21h, pressft drill bit, 2. 1 mm, hip, device drill tip broke off while drilling a hole for the anchor and was not able to be removed from patient. This event took place during a hip arthroscopy on (b)(6) 2018 causing a 10-minute delay in the procedure. The procedure was completed successfully using an alternate device. The tip was not removed from that patient due to being too difficult to remove being that it was embedded in the bone. It was reported that there was no injury to the patient or the user. No extended hospitalization or surgical intervention was required. This report is being raised on the basis of injury due to the tip being left in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2018-00142 |
| MDR Report Key | 7843937 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-04 |
| Date of Report | 2018-09-04 |
| Date of Event | 2018-08-08 |
| Date Mfgr Received | 2018-08-09 |
| Device Manufacturer Date | 2017-06-26 |
| Date Added to Maude | 2018-09-04 |
| 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 | MR. JOHN BERGA |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995358 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESSFT DRILL BIT, 2.1MM, HIP |
| Generic Name | BIT, SURGICAL |
| Product Code | GFG |
| Date Received | 2018-09-04 |
| Returned To Mfg | 2018-08-31 |
| Catalog Number | NDB21H |
| Lot Number | 846966 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 11311 CONCEPT BLVD. LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-04 |