MAUDE Adverse Event Report: SYNTHES GMBH FIBULINK; WASHER, BOLT NUT

Model Number FGS-1000

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

Patient Problem Foreign Body In Patient (2687)

Event Date 10/27/2021

Event Type  malfunction  

Event Description

While drilling the patient¿s bone, the tip of the drill bit broke while it was still inside the bone.Surgeon decided to leave the broken tip inside, according to him it would have caused more harm to retrieve it and it is not harmful to leave it inside the patient¿s bone.Surgeon decided to look at post op x-rays to determine the size of broken piece.Manufacturer response for implants (screw, drill bit, depuy synthes (per site reporter).The vendor rep has been informed of the incident, they will report the event to their company.

• Brand Name: FIBULINK
• Type of Device: WASHER, BOLT NUT
• Manufacturer (Section D): SYNTHES GMBH; 1302 wrights lane e; west chester PA 19380
• MDR Report Key: 12744443
• MDR Text Key: 279863264
• Report Number: 12744443
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-1000
• Device Catalogue Number: FGS1000
• Device Lot Number: 21E018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA