MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-28 for DRILL TAPERED 3.5X13MM 29368 manufactured by Nobel Biocare Ab.
[146490378]
Internal reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146490379]
Issue description: the customer reported to nobel biocare on (b)(6) 2019 that on (b)(6) 2019 the 'drill tapered 3. 5x13mm' was used on a patient and stainless steel residue from the drill was housed in the patient's bone. The customer indicated that no patient injury occurred and informed nobel biocare on (b)(6) 2019 that the patient has not experienced any adverse effects, however the stainless steel residue is material not intended to stay in the body (i. E. Foreign body reaction). The stainless steel residue may potentially contribute to implant failure (of implants nearby) in the future which could result in an injury and require medical intervention. Investigation: the instructions for use (ifu) makes the customer aware that the tooling must be maintained in good shape. The sterilization guideline informs the customer that for drills a functional check must be performed during cleaning, and damaged, dull, worn out tools must be disposed. The ifu also states that there is no maximum number of uses defined as this depends on several factors. However, it is made clear that these devices must be replaced at end of serviceable life. The customer informed nobel biocare that they used the drill more than 15 times prior to the event. Root cause: the returned product was received opened and used by nobel biocare. The customer was unable to provide material number. Visual inspection and measurement were used to identify the correct material number. Visual inspection showed a drill tapered with debris on the latch and blades. The instrument appeared worn. The blades were damaged. The customer was unable to provide the correct batch number. Therefore the complaint history could not be reviewed for a possible trend. The issue was most likely caused by recurrent and improper use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611992-2019-00001 |
| MDR Report Key | 8645783 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-28 |
| Date of Report | 2019-04-29 |
| Date of Event | 2019-04-18 |
| Date Mfgr Received | 2019-04-29 |
| Date Added to Maude | 2019-05-28 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. WILLEM VAN ALST |
| Manufacturer Street | KOZAKKENBERG 4 |
| Manufacturer City | BELFELD, 5951DL |
| Manufacturer Country | NL |
| Manufacturer Postal | 5951DL |
| Manufacturer G1 | NOBEL BIOCARE AB |
| Manufacturer Street | VASTRA HAMNGATAN 1 |
| Manufacturer City | G 411 17 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 411 17 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRILL TAPERED 3.5X13MM |
| Generic Name | DRILL, BONE, POWERED |
| Product Code | DZI |
| Date Received | 2019-05-28 |
| Returned To Mfg | 2019-05-02 |
| Catalog Number | 29368 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOBEL BIOCARE AB |
| Manufacturer Address | VASTRA HAMNGATAN 1 G?TEBORG, V?STRA G?TALANDS L?N 411 17 SW 411 17 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-28 |