MAUDE Adverse Event Report: LIMACORPORATE S.P.A. REVERSE ADAPTOR SLEEVE

Model Number 9013.52.141

Device Problems Bent (1059); Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Manufacturer Narrative

We should receive the instrument involved and all the other info requested to conduct a proper investigation.We will provide a final mdr once the analysis will be concluded.

Event Description

During surgery, smr reverse adaptor sleeve (model # 9013.52.141, lot# 2014aa534) would not hold the conical reamer guide.According to the info reported, it was not possible for the sleeve to tighten the reamer guide peg probably due to bent prongs of the reverse adaptor sleeve.Surgeon had to use pliers to bend prongs back in place.Surgery time prolonged of 5 minutes.No reported consequences for the patient.Event happened in us.

• Brand Name: REVERSE ADAPTOR SLEEVE
• Type of Device: REVERSE ADAPTOR SLEEVE
• 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: 6310478
• MDR Text Key: 67229181
• Report Number: 3008021110-2017-00006
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• 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: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.52.141
• Device Lot Number: 2014AA534
• 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