TRINITY
Received Jan 27, 2025 · Event occurred Jan 9, 2025
Report 9614209-2025-00429 · MDR key 21239399
Device
Product problems
- Mechanical Jam
- Mechanical Jam
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PER -9254 FINAL REPORT. ADDITIONAL INFORMATION, INCLUDING THE DEVICE LOT CODES AND PHOTOGRAPHS OF THE DEVICES WAS REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, HOWEVER, THIS INFORMATION HAS NOT BEEN PROVIDED AND THUS NO INVESTIGATION COULD BE PERFORMED. THE DEVICE LOT CODES HAVE NOT BEEN PROVIDED AND THUS THE RELEVANT DEVICE MANUFACTURING RECORDS COULD NOT BE IDENTIFIED OR REVIEWED. NO INVESTIGATION IS POSSIBLE DUE TO THE LACK OF INFORMATION PROVIDED AND THE REPORTED EVENT COULD NOT BE VERIFIED. THIS CASE IS NOW CONSIDERED CLOSED, HOWEVER, SHOULD ANY ADDITIONAL INFORMATION BE PROVIDED THEN THIS CASE CAN BE RE-OPENED FOR INVESTIGATION. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.
Description of Event or Problem
TRINITY INTRODUCER / IMPACTOR HANDLE WOULD NOT UNSCREW FROM THE IMPLANT AFTER IMPACTION. SHELL REMOVED FROM THE ACETABULUM STILL ATTACHED TO THE HANDLE AND NEW DEVICES LOCATED / USED.
Description of Event or Problem
TRINITY INTRODUCER / IMPACTOR HANDLE WOULD NOT UNSCREW FROM THE IMPLANT AFTER IMPACTION. SHELL REMOVED FROM THE ACETABULUM STILL ATTACHED TO THE HANDLE AND NEW DEVICES LOCATED / USED.
Additional Manufacturer Narrative
PER -9254 INITIAL REPORT. ADDITIONAL INFORMATION, INCLUDING THE DEVICE LOT CODES AND PHOTOGRAPHS OF THE DEVICES HAD BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. UPON RECEIPT OF THE DEVICE LOT CODES, THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.