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 2019-03-16 for TI LOW PROFILE NEURO SCREW SELF-DRILLING 3MM 400.833 manufactured by Oberdorf Synthes Produktions Gmbh.
[139052191]
The device was received. (b)(6). Without a lot number the device history records review could not be completed. Investigation summary investigation selection: investigation site: (b)(4); selected flow(s): 5. Broken. Visual inspection: upon visual inspection: we have received seven (7) screws, three (3) 400. 833 and four (4) 400. 834, with no lot number reported/provided for investigation. Every screw has a broken off tip, just a bit of the shank is still visible on the screw head (we do not know where the missing parts are). Furthermore, all recess's show signs of usage, a few are even badly worn. This thus confirming the complaint description. Document/specification review: not required per selected investigation flow, as it is a post-manufacturing caused use related damage at the device. Dimensional inspection: not required per selected investigation flow, as it is a post-manufacturing caused use related damage at the device. Material or hardness review: not required per selected investigation flow, as it is a post-manufacturing caused use related damage at the device. Summary: the received condition of the device is concordant with the complaint description and the complaint condition is confirmed. Unfortunately, we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place or/and that during the operation excessive force (too much mechanical force whilst inserting into the bone) led to this damage. As these screws are very small and quite fragile, a lot of care is required while handling. We can confirm the visible damages are not from any manufacturing non-conformity. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. 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
[139052192]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, during an unknown procedure, the seven (7) cranial screws got damaged while tapping. It was unknown if there was a surgical delay. Patient outcome was unknown. This report is for (1) ti low profile neuro screw self-drilling 3mm. This complaint involves seven (7) devices. This report is 4 of 7 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-62007 |
| MDR Report Key | 8426631 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-16 |
| Date of Report | 2018-12-25 |
| Date of Event | 2018-12-24 |
| Date Mfgr Received | 2019-03-18 |
| Date Added to Maude | 2019-03-16 |
| 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 | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 4436 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TI LOW PROFILE NEURO SCREW SELF-DRILLING 3MM |
| Generic Name | SCREW FIXATION INTRAOSSEOUS |
| Product Code | DZL |
| Date Received | 2019-03-16 |
| Returned To Mfg | 2019-02-04 |
| Catalog Number | 400.833 |
| 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 | 2019-03-16 |