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); Component Falling (1105); Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

No anomaly detected by checking the dhr of the lot # involved (2014aa488) on a total of (b)(4) physica drill bits manufactured with the same lot #.No other complaints reported on this specific lot#.We will submit a final emdr when the investigation will be completed.

Event Description

Intra operative breakage of a physica drill bit, model# 9065.10.380, lot# 2014aa488.According to the info reported, the femoral drill bit simply broke off while the surgeon was drilling the two holes in the femoral sizer.No reported consequences for the patient.Thirty seconds - 1 minute was the estimated time to pull the broken bit out of the cancellous bone.Sixty estimated usages of the drill bit involved in this intra-op issue have been reported.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, 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: 6492854
• MDR Text Key: 73100443
• Report Number: 3008021110-2017-00025
• 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

• Date FDA Received: 04/14/2017
• 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: 2014AA488
• 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