MAUDE Adverse Event Report: AESCULAP AG BICORTICAL SCREW DRILL BIT 3.2MM DIA.; OR TECHNOLOGY ORTHOPAEDICS

Model Number NP615R

Device Problem Material Fragmentation (1261)

Patient Problem Failure to Anastomose (1028)

Event Date 09/12/2023

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 the product np615r - bicortical screw drill bit 3.2mm dia.According to the complaint description, the drill broke while the doctor was busy drilling the hole for the fixating of the femur screw of the navigation tower.The piece of drill that broke off was left in the patient because it could not be retrieved.A fragment remained in situ.Additional information was not provided nor available.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

• Brand Name: BICORTICAL SCREW DRILL BIT 3.2MM DIA.
• Type of Device: OR TECHNOLOGY ORTHOPAEDICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17896425
• MDR Text Key: 325823619
• Report Number: 9610612-2023-00224
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NP615R
• Device Catalogue Number: NP615R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1