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

Model Number 9013.52.116

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

Checking the manufacturing charts of the involved lots #17aq0vk and #15aa077, no pre-existing anomaly was found on the instruments manufactured with the same lot #s.We submit a final mdr when the investigation is complete.

Event Description

During a primary shoulder surgery performed on (b)(6) 2023, the following instruments were reported to malfunction: · smr - guide for conical reamer (product code 9013.52.116, lot #17aq0vk) · smr - tt metal back impactor (product code 9013.75.385, lot #15aa077) in details, the guide for conical reamer had a broken taper and didn't engage with the stem to ream for the reverse body.The surgeon reamed without using a guide.The tt metal back impactor had the black handle sleeve slightly loose, making it harder to position the glenosphere.Due to the malfunctioning, the surgical time got extended of 15 minutes.It was reported that the surgeon was happy with the final seating and positioning of the implant.Event happened in australia.

Event Description

During a primary shoulder surgery performed on (b)(6) 2023, the following instruments were reported to malfunction: smr - guide for conical reamer (product code 9013.52.116, lot #17aq0vk) smr - tt metal back impactor (product code 9013.75.385, lot #15aa077).In details, the guide for conical reamer had a broken taper and didn't engage with the stem to ream for the reverse body.The surgeon reamed without using a guide.The tt metal back impactor had the black handle sleeve slightly loose, making it harder to position the glenosphere.Due to the malfunctioning, the surgical time got extended of 15 minutes.It was reported that the surgeon was happy with the final seating and positioning of the implant.Event happened in australia.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #17aq0vk, no pre-existing anomaly was found on a total of 56 devices manufactured with the same lot #.Checking the manufacturing charts of the involved lot #15aa077, no pre-existing anomaly was found on a total of 35 devices manufactured with the same lot #.This is the first and only complaint received on that lot #.Device analysis the guide for conical reamer has been returned to limacorporate for analysis.The visual inspection didn't detect any anomaly.The instrument is intended to couple to the trial stem of the proper size to prepare the humerus for the insertion of the reverse body.A functional analysis has been performed with the returned guide.The instrument was coupled to a trial stem and no engagement issue with the stem was found.Moreover, the safety screw could be properly tightened.Therefore, the reported issue is not confirmed.It is hypothesized that the guide has been coupled to a worn or damaged trial stem, or that during the surgery, the guide hasn't properly engaged to the trial stem due to the presence of debris or other materials that could interpose between the contacting surfaces.No information has been shared on the trial stem used in the surgery.The tt metal back impactor involved in the complaint has been returned to limacorporate for analysis.The inspection of the instrument confirmed that the welding of the terminal flange on the sleeve has failed.It should be noted that the instrument was manufactured in 2015, therefore it served the market for about 9 years.It is therefore hypothesized that wear and tear of the instrument due to multiple uses over time have led to the failing and thus to the loosening of the handle sleeve.Considering that: check of manufacturing charts highlighted no anomalies on components manufactured with lot #17aq0vk and #15aa077; the analysis performed on the returned guide didn't confirm the reported issue as the instrument properly engaged to a trial stem; the analysis performed on the returned metalback impactor confirmed that the welding of the terminal flange on the sleeve has failed due to wear and tear of the instrument; we can state that the event was not product related.Pms data according to our pms data, we can estimate the occurrence rate of malfunctioning of the guide for conical reamer (product code 9013.52.116) and of the tt metal back impactor (product code 9013.75.385) to be 1.95% and 0.10% respectively (ww).Please note that this occurrence rate is overestimated because it does not consider the reuse of the instruments but only the total number of pieces manufactured.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions are required for this specific case.Limacorporate continues monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

• Brand Name: SMR - GUIDE FOR CONICAL REAMER
• Type of Device: GUIDE FOR CONICAL REAMER
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 18526692
• MDR Text Key: 333442719
• Report Number: 3008021110-2024-00006
• Device Sequence Number: 1
• Product Code: PHX
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2024

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 Model Number: 9013.52.116
• Device Lot Number: 17AQ0VK
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2024
• 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): Other