MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR INSERTER-EXTRACTOR HANDLE

Model Number 9013.02.303

Device Problem Connection Problem (2900)

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

Event Date 07/29/2015

Event Type  malfunction  

Manufacturer Narrative

No anomalies which could have contributed to the issue by checking the manufacturing charts of the lot number of instrument involved.No other similar complaints registered on these lot number, on a total of (b)(6) (handles) and (b)(6) (sleeves) instruments manufactured with these lot number.We will receive the instruments involved and analyze them before submitting our final report.

Event Description

Intra-op issue during a surgery dated (b)(6) 2015.It was difficult to insert the sleeve (product code 9013.52.141) onto the handle (product code 9013.02.303).It appeared that the problem was in the handle.The event occurred in (b)(6).

Manufacturer Narrative

No anomalies which could have contributed to the issue by checking the manufacturing charts of the lot # of handle involved.No other similar complaints registered on this lot #, on a total of (b)(4) (handles) manufactured with this lot #.We received the handle involved.A dimensional check was performed on the handle and no anomaly was detected on the part of the instrument intended to be connected to the sleeve.The functionality of the handle was tested with a sleeve available in house and the coupling handle-sleeve was functional.A total of three (3) similar complaints were reported, involving difficulty to engage/disengage the sleeve to the handle, on a total of (b)(4) smr inserter-extractor handle manufactured with the product codes 9013.02.302-9013.02.303.The other two cases are still under evaluation (instruments involved not returned yet).No corrective action has been planned for this specific event.Limacorporate will keep monitoring the market on the reoccurrence of this event.

Event Description

Intra-op issue during a surgery dated (b)(6) 2015.It was difficult to insert the sleeve (product code 9013.52.141) onto the handle (product code 9013.02.303).It appeared that the problem was in the handle.Event occured in (b)(6).

• Brand Name: SMR INSERTER-EXTRACTOR HANDLE
• Type of Device: SMR INSERTER-EXTRACTOR HANDLE
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, italy (udine) 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, italy (udine) 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 5147292
• MDR Text Key: 28612799
• Report Number: 3008021110-2015-00041
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.02.303
• Device Lot Number: 14AA538
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2014
• 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
• Patient Outcome(s): Hospitalization