MAUDE Adverse Event Report: AESCULAP AG IMPACTION INSTR.F/HIP PROSTHESES/HEADS; HIP ENDOPROSTHETICS

Model Number ND060

Device Problems Crack (1135); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with an impaction instrument.According to the complaint description the plastic section of the instrument chipped and cracked during surgery.Surgical procedure: total hip arthroplasty (tha).This malfunction prolonged the surgery for 15 minutes.There was no patient harm.Additional information has been requested.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: the device was not provided for investigation.Therefore a investigation of the device itself was not possible.Due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Based on the provided information and without a product for investigation, a clear conclusion can not be drawn.Based on the investigations and results of the 8d report no capa is necessary.

• Brand Name: IMPACTION INSTR.F/HIP PROSTHESES/HEADS
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10438523
• MDR Text Key: 204218313
• Report Number: 9610612-2020-00439
• Device Sequence Number: 1
• Product Code: HWA
• 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: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ND060
• Device Catalogue Number: ND060
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1