ANCHOR BOLTS LSBK1-AX-06

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-02 for ANCHOR BOLTS LSBK1-AX-06 manufactured by Ad-tech Medical Instrument Corp..

Event Text Entries

[146915170] An internal complaint investigation was performed for this issue. Specifically, a historical complaints review was completed for the alleged deficiency "broken anchor bolts". There have been 13 similar complaints for anchor bolts breaking between january 1, 2017 and march 18, 2019. A capa and investigation review was also conducted for the alleged deficiency "anchor bolt broke during implantation" and there have been no capas or investigations opened for this issue to date. A batch record review was conducted; (b)(4) lsbk1-ax-06 anchor bolts were planned for this work order and (b)(4) were completed. No issues were noted in the work order process notes that would contribute to the reported complaint. All (b)(4) lsbk1-ax-06 anchor bolts passed the in-process and final qc checks. No product return analysis could be performed for this complaint as no product was returned. According to the customer's sales representative, the patient's skull was thicker and required more force to place the bolt. The neurosurgeon was more aggressive when attempting to insert (i. E. , screw in) this bolt into the skull; thus resulting in the bolt snapping. The risk level for this issue remains alap (as low as possible). Additionally, based on a review of previous complaints for anchor bolt breakages and an analysis of all anchor bolt breakage complaint data, the current rate of anchor bolt breakage complaints versus products sold is very low; (b)(4) over the past 2 years. Ad-tech is continuing to monitor this issue closely.
Patient Sequence No: 1, Text Type: N, H10


[146915171] On march 15, 2019, ad-tech received a copy of a medwatch 3500a report from the food and drug administration (fda). The report was from a user facility (uf), documented under uf report # (b)(4). According to the form, it was stated that, "... When inserting the anchor bolt, the bolt snapped... " part of the bolt remained in the skull and a needle driver was used to secure the anchor bolt, thus enabling the bolt to be unscrewed for removal. According to the user facility, they were not aware of any other information about the patient that may have influenced the outcome of the event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183456-2019-00001
MDR Report Key8472930
Report SourceUSER FACILITY
Date Received2019-04-02
Date of Report2019-03-25
Date Facility Aware2019-02-01
Report Date2019-03-15
Date Reported to Mfgr2019-03-15
Date Mfgr Received2019-03-15
Device Manufacturer Date2018-06-11
Date Added to Maude2019-04-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. KATHLEEN BARLOW
Manufacturer Street400 WEST OAKVIEW PARKWAY
Manufacturer CityOAK CREEK WI 53154
Manufacturer CountryUS
Manufacturer Postal53154
Manufacturer Phone2626341555
Manufacturer G1AD-TECH MEDICAL INSTRUMENT CORP.
Manufacturer Street400 WEST OAKVIEW PARKWAY
Manufacturer CityOAK CREEK WI 53154
Manufacturer CountryUS
Manufacturer Postal Code53154
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameANCHOR BOLTS
Generic NameANCHOR BOLT (ACCESSORY TO DEPTH ELECTRODES)
Product CodeGZL
Date Received2019-04-02
Catalog NumberLSBK1-AX-06
Lot Number208140678/0121088
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age1 DA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAD-TECH MEDICAL INSTRUMENT CORP.
Manufacturer Address400 WEST OAKVIEW PARKWAY OAK CREEK 53154 US 53154


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-04-02

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