MAUDE Adverse Event Report: STRYKER GMBH DRILL, TRI-FLAT GAMMA3® Ø4,2X360 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 13203645

Device Problems Break (1069); Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2024

Event Type  malfunction  

Event Description

As reported: "orif for right hip of a patient was performed on (b)(6) 2024.When the surgeon used the drill and the distal targeting system to fix the distal locking screw of the femoral interlocking nail from the side, the drill was broken and the tip of the drill was lodged in the bone.The broken drill tip was removed by scrapping the surrounding bone.After that, orif was completed by drilling another screw hole using another drill.".

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

• Brand Name: DRILL, TRI-FLAT GAMMA3® Ø4,2X360 MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18865715
• MDR Text Key: 337211632
• Report Number: 0009610622-2024-00095
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13203645
• Device Lot Number: KU104335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention