PIVOTPOST & CLAMP
Received May 29, 2024 · Event occurred Feb 23, 2022
Report 1220246-2024-04232 · MDR key 19417209
Device
Generic name
Operating Room Table Access
Manufacturer
Arthrex, Inc.Model number
PIVOTPOST & CLAMPCatalog number
AR-1560
Lot number
UNK
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER PROVIDED PHOTO, WHICH DISPLAYS A PIECE ON TOP OF THE BLACK KNOB BROKE. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER-APPLIED EXCESSIVE MECHANICAL FORCES.
Description of Event or Problem
ON 02/23/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-1560 PIVOTPOST & CLAMPS BLACK KNOB TO TIGHTEN DOWN THE CLAMP TO THE BED BROKE. THIS WAS DISCOVERED DURING AN UNKNOWN TIME WITH NO PATIENT EFFECT REPORTED.