MAUDE Adverse Event Report: PMT CORPORATION PMT ANCHOR BOLT

Model Number	2103-19-30
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reported problem: (2) 30mm bolts broke in the skull and the doctor ended up abandoning the sites and had to dig them out.I was told dr.(b)(6) had to re-drill multiple times at the same site because he was having trouble accurately placing the anchor bolt.
Additional Manufacturer Narrative
The review of tracer sheets and inspections records showed that there was no manufacturing error for these specific anchor bolts.Based on pmt's experience with destructive testing of the anchor bolts and comparing with the pictures provided, these bolts broke due to high amounts of torsional force.When anchor bolts are placed by the user, the threaded portion of the bolt is under the highest amount of torsion, which is why we see in the pictures that both bolts broke in this threaded area.Pmt has validated the strength of the anchor bolts to be confident that the design of the devices allow them to withstand the normal torsion forces experience in use.It is possible that the user was not placing the bolts orthogonally as intended, but was instead trying to screw them in at an angle which can introduce additional shear forces to the bolt.However, without any further information as to the exact method of placement from the customer, there is no way for pmt to determine the exact reason for how such high torsional forces were placed on the bolt, nor if this was a product malfunction.

• Brand Name: PMT ANCHOR BOLT
• Common Device Name: ANCHOR BOLT
• Manufacturer (Section D): PMT CORPORATION; 1500 park road; chanhassen MN 55317
• Manufacturer (Section G): PMT CORPORATION; 1500 park road; chanhassen MN 55317
• Manufacturer Contact: kim schmelzer ; 1500 park road; chanhassen, MN 55317 ; 9524700866
• MDR Report Key: 21732986
• Report Number: 2182979-2025-00002
• Device Sequence Number: 20989183
• Product Code: GZL
• UDI-Device Identifier: 00650551039051
• UDI-Public: 00650551039051
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K970418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2103-19-30
• Device Catalogue Number: 2103-19-30
• Device Lot Number: 080921, 092121 OR 031224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown