FDA Adverse Event Malfunction Summary report: N

SAW GUIDE A, 2MM

MDR report key: 23362511 · Received October 22, 2025

Report

Report Number
2031009-2025-00025
Event Type
Malfunction
Date Received
October 22, 2025
Date of Event
September 23, 2025
Report Date
October 22, 2025
Manufacturer
TRIMED, INC.
Product Code
LXH
UDI-DI
00842188112256
PMA / PMN Number
EXEMPT
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
WA, US
Reporter Occupation
003

Narratives

Description of Event or Problem · 0

SALES REP REPORTED ON 23SEP2025 THAT WHILE COVERING A (B)(6) CASE WITH A SURGEON AND A (B)(6) RESIDENT (LEADING), THEY ENCOUNTERED AN ISSUE WITH THE 2MM A CUT GUIDE. IT WAS STATED THAT FOLLOWING SOME DIFFICULTY MAKING THE INITIAL CUT, THE SURGEON NOTICED THAT THE A CUT GUIDE WAS SLIGHTLY BENT. IT WAS UNCLEAR IF IT MIGHT HAVE BEEN SLIGHTLY BENT INITIALLY OR IF SOMETHING DURING THE CASE CAUSED THE GUIDE TO BEND. REGARDLESS, THEY DECIDED TO REVISE AFTER MAKING THE B CUT RESULTING IN A LARGER WEDGE THAN PLANNED. IT WAS STATED THAT THE DEVICE CAME IN CONTACT WITH THE PATIENT PER PLANNED PROCEDURE HOWEVER THIS CAUSED OVER A 20-MINUTE DELAY IN SURGERY DUE TO THE REPEATED CUT REVISION. THE REP PROVIDED ADDITIONAL INFORMATION ON (B)(6) 2025 THAT PERMANENT DAMAGE/IMPAIRMENT IS UNCLEAR DUE TO POSSIBLE NEGATIVE ULNAR VARIANCE SEQUELAE. HE STATED THAT HE ASSUMES THE OSTEOTOMY WILL HEAL DUE TO ADEQUATE COMPRESSION (UNCLEAR IF THERE MAY BE SUBSEQUENT SYMPTOMS/IATROGENIC RADIOCARPAL OVERLOAD), HOWEVER THERE WAS NO MENTION OF POSSIBLE FURTHER INTERVENTION. THE SURGEON DID NOT MENTION ANY SUSPECTED NEED FOR FURTHER INTERVENTION FOLLOWING THE CASE AND HE DID NOT APPEAR PARTICULARLY PLEASED WITH THE ENLARGED WEDGE BUT WAS SATISFIED ENOUGH WITH THE RESULT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1446921 SAW GUIDE A, 2MM SAW GUIDE A, 2MM LXH TRIMED, INC. UOSG-A-2 00842188112256

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown