MAUDE Adverse Event Report: LIMACORPORATE S.P.A. HEADED DRILL FOR FEMORAL A/P SIZER

Model Number 9065.10.380

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

No anomaly detected by checking the dhr of the lot # involved (2016ag01x) on a total of (b)(4) devices manufactured with the same lot #.We will submit a final emdr when the investigation will be completed.

Event Description

Intra-operative breakage of a physica drill bit.According to the info reported, the femoral drill bit broke while the surgeon was drilling the holes in the femoral sizer.No reported consequences for the patient and no prolonged surgery time.Surgeon used the 3mm drill out of the tibial tray to complete the drilling operation.He was also able to remove all the pieces of the broken drill bit by using a pair of needle drivers.Event happened in us.

• Brand Name: HEADED DRILL FOR FEMORAL A/P SIZER
• Type of Device: HEADED DRILL FOR FEMORAL A/P SIZER
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer Contact: giulio puppa
• MDR Report Key: 6435303
• MDR Text Key: 71209080
• Report Number: 3008021110-2017-00017
• 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

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: 9065.10.380
• Device Lot Number: 2016AG01X
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2017
• 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