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

Model Number 9013.52.116

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

By checking the manufacturing chart of the lot# of the instrument involved, no anomaly was found.We will submit a final report after final investigation.

Event Description

Intra-operative issue happened on the (b)(6) 2019.During a total shoulder replacement, the conical reamer pilot screw (code #9013.52.116, lot #15aa017) was stuck in the trial and the surgeon had trouble to unscrew it.Event occurred in (b)(6).

Manufacturer Narrative

We received code and lot number only for the smr guide for conical reamer, no product info about the trial stem size 16mm.Therefore, we could only check the dhrs of the lot # of the guide involved (lot #2015aa017): no pre-existing anomalies were found on the 61 pieces manufactured with the same lot#.The number of uses of the instrument is not known.We did not receive the instruments back for analysis, therefore a deeper analysis is not possible: no visual, functional nor dimensional check can be performed on the specific instruments involved.We are aware of only another similar intra-op issue where the guide code 9013.52.116 got stuck into the trial stem.The analysis on that previous case, showed that the issue was most probably related to the trial stem than to the guide (failed welding of an internal pin after repeated uses of the trial stem itself).Unfortunately, without the instruments in our hands and without even knowing the code and lot# of the involved trial stem, no deeper investigation can be done to confirm/exclude if the trial stem conditions could have somehow contributed to the issue.Based on the very few available info, a definitive conclusion cannot be drawn.We can only exclude the presence of pre-existing anomaly on the involved guide (based on the dhr check, the guide was manufactured in compliance to the specifications, no deviation detected).No additional checks can be performed, therefore, at the present stage, we cannot classify this event as product-related.Limacorporate is aware of 2 similar cases (guide 9013.52.116 stuck in the trial stem) on a total of 443 guides with code 9013.52.116 manufactured.Thus, specific occurrence rate is 0.45%.Please, consider that occurrence rate is overestimated because it was not possible to consider the real number of uses of the smr guide for conical reamer (reusable instruments) placed on the market.No specific action for this case, limacorporate will continue monitoring the market to promptly detect any further similar event.

Event Description

Intra-operative issue happened on the (b)(6) 2019: during a total shoulder replacement, the conical reamer guide (code #9013.52.116, lot #15aa017) got stuck in the trial stem size 16mm (code/lot# not known) and the surgeon had trouble to unscrew the screw of the guide from the trial stem.Eventually, the surgeon succeeded in disengaging the two instruments with the help of a mallet and completed the surgery with only 2 minutes of delay.No other consequences reported for the patient.Event occurred in australia.

• Brand Name: GUIDE FOR CONICAL REAMER
• Type of Device: GUIDE FOR CONICAL REAMER
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via naizonale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 8452428
• MDR Text Key: 140152493
• Report Number: 3008021110-2019-00031
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K110598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

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: No Information
• Device Model Number: 9013.52.116
• Device Lot Number: 15AA017
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization