MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA - FEMORAL ALIGNMENT

Model Number 9065.10.020

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

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

Event Type  malfunction  

Manufacturer Narrative

The check of the dhr of the lot # involved (lot #2016ag01g) did not show any anomalies on the (b)(4) pieces manufactured with this lot#.No other complaints reported on this lot#.We will send a final report once the investigation will be concluded.

Event Description

Intraoperative breakage of a femoral alignment guide, model# 9065.10.020, lot# 2016ag01tg.According to the info reported, during surgery the pin fell out.No reported consequences for the patient.Surgery time extended of 5 minutes due to the fact that another instrument set was opened to replace the broken part.Estimated number of uses of the instrument: more than 50.Event occurred in us.

• Brand Name: PHYSICA - FEMORAL ALIGNMENT
• Type of Device: PHYSICA - FEMORAL ALIGNMENT
• 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 ; IT
• MDR Report Key: 6753611
• MDR Text Key: 81586083
• Report Number: 3008021110-2017-00066
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9065.10.020
• Device Lot Number: 2016AG01G
• Was the Report Sent to FDA?: 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