MAUDE Adverse Event Report: GSOURCE LLC GSOURCE; BIT, DRILL

Model Number GS 86.8220

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/05/2022

Event Type  malfunction  

Event Description

During the patient's arthroplasty replacement total right hip the tip of the drill bit used to drill the holes in the posterior femur for the capsular repair broke off.The tip was noted to be retained in the greater trochanter, and confirmed by x-ray.

• Brand Name: GSOURCE
• Type of Device: BIT, DRILL
• Manufacturer (Section D): GSOURCE LLC; 19 bland st; emerson NJ 07630
• MDR Report Key: 16136874
• MDR Text Key: 307077311
• Report Number: 16136874
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GS 86.8220
• Device Catalogue Number: GS 86.8220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1