MAUDE Adverse Event Report: AESCULAP AG TRIAL INSERT G 32MM SYM.; INSTRUMENT FOR HIP ENDOPROSTHETIC SURGERY

Model Number NT503

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Intra-operative feathering burr in long hole when applying with forceps and fragments were breaking off; fragments may remain in patient.No harm to the patient, no delay to procedure reported.

Manufacturer Narrative

Manufacturing site evaluation: samples received: 8 trail inserts were provided for investigation.Analysis and results: the trial inserts show several damages around the long holes, which appear to have occurred due to incorrect placement of the forceps.The forceps may have slipped out of the long holes leaving the damage.There are no other complaints on file for this product/issue, therefore a systematical error in manufacturing and in materials has been excluded.Final conclusion: complaint is not justified.The failure is user related.Corrective/preventive actions: there are no safety problem and all the regulatory requirements have been met.Please note that the follow up mdr dated 02/25/2016 had the incorrect medwatch number 3005673-2015-00136.Per request of the fda the follow up has been corrected and re-submitted.

• Brand Name: TRIAL INSERT G 32MM SYM.
• Type of Device: INSTRUMENT FOR HIP ENDOPROSTHETIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 5112432
• MDR Text Key: 27177338
• Report Number: 3005673311-2015-00136
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NT503
• Device Catalogue Number: NT503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2015
• Date Manufacturer Received: 12/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other