MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR GUIDE FOR CONICAL REAMER; KWS

Model Number 9013.52.116

Device Problems Loose or Intermittent Connection (1371); Component Missing (2306)

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

Event Date 06/15/2015

Event Type  malfunction  

Manufacturer Narrative

The pin moved from its original position during surgery and this probably happened during surgery, even if the event was noticed only after surgery , without any impact for the patient.We checked the manufacturing chart of the lot # involved ((b)(4)) without finding any anomaly.A total of 61 smr guides for conical reamer were manufactured with this lot #, and this is the only complaint received on this lot # and product code.We received the instrument involved and we analysed it.The pin welding is compromised, making the pin loose and allowing it to move inside the hole, this is the likely cause of the issue detected.According to the above information, we believe that this issue is related to a single piece (yielding of the welding on a single piece).No corrective actions have been planned for this case.Limacorporate will keep monitored the market.

Event Description

The smr guide for conical reamer was found to be missing the screw and the spring, due to loosening of the pin that keeps the screw and the spring in place.The damage was detected after surgery and did not have any impact on the patient.The event occurred in (b)(6).

• Brand Name: SMR GUIDE FOR CONICAL REAMER
• Type of Device: KWS
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; san daniele del friuli, udine 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; IT
• Manufacturer Contact: giulio puppa ; IT
• MDR Report Key: 4941803
• MDR Text Key: 23020620
• Report Number: 3008021110-2015-00028
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Report Date: 06/25/2015

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: Other
• Device Model Number: 9013.52.116
• Device Lot Number: 2015AA017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2015
• 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