MAUDE Adverse Event Report: LIMACORPORATE S.P.A. HEADED DRILL FOR FEMORAL A/P SIZER; PHYSICA - DISTAL HOLE DRILL

Model Number 9065.10.380

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

We will provide a final report once the investigation will be concluded.

Event Description

Intra operative breakage of a physica drill bit happened on (b)(6) 2017 during a knee surgery.According to the info reported, broken end of the drill bit was removed from the distal femur by the surgeon using pliers.No reported consequences for the patient.Prolonged surgery time of about one minute.Event happened in us.

• Brand Name: HEADED DRILL FOR FEMORAL A/P SIZER
• Type of Device: PHYSICA - DISTAL HOLE DRILL
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale, 52; villanova di san daniele, 33038 ; IT 33038 ; 2 945511
• MDR Report Key: 6348878
• MDR Text Key: 68280437
• Report Number: 3008021110-2017-00010
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K141934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9065.10.380
• Device Lot Number: 16AG01X
• 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