TI LOW PROFILE NEURO SCREW SELF-DRILLING 3MM 400.833

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number8030965-2019-62007
MDR Report Key8426631
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-03-16
Date of Report2018-12-25
Date of Event2018-12-24
Date Mfgr Received2019-03-18
Date Added to Maude2019-03-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer StreetEIMATTSTRASSE 3
Manufacturer CityOBERDORF 4436
Manufacturer CountrySZ
Manufacturer Postal4436
Manufacturer Phone6103142063
Manufacturer G1MONUMENT
Manufacturer Street1101 SYNTHES AVENUE
Manufacturer CityMONUMENT CO 80132
Manufacturer CountryUS
Manufacturer Postal Code80132
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTI LOW PROFILE NEURO SCREW SELF-DRILLING 3MM
Generic NameSCREW FIXATION INTRAOSSEOUS
Product CodeDZL
Date Received2019-03-16
Returned To Mfg2019-02-04
Catalog Number400.833
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOBERDORF SYNTHES PRODUKTIONS GMBH
Manufacturer AddressEIMATTSTRASSE 3 OBERDORF 4436 SZ 4436


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-16

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