MAUDE Adverse Event Report: LIMACORPORATE S.P.A. RASP HANDLE

Model Number 9035.05.190

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

No anomalies detected by checking the manufacturing chart related to lot# 2015ar08t.This is the first and only complaint received by limacorporate on this specific lot# on a total of (b)(4) pieces manufactured with this lot#.No indication of lot #issue.We will send a final mdr once the investigation will be concluded.

Event Description

Intraoperative malfunction of a master sl broach handle, model #9035.05.190, lot#2015ar08t.According to the info reported, the broach handle could not engage the broach when the handle was closed, probably due to the over use of the handle.Estimated number of uses of the handle: 60/70.Event happened in us.

• Brand Name: RASP HANDLE
• Type of Device: RASP HANDLE
• 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: 6841169
• MDR Text Key: 85608910
• Report Number: 3008021110-2017-00079
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140975
• 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: 9035.05.190
• Device Lot Number: 2015AR08T
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1