MAUDE Adverse Event Report: LIMACORPORATE S.P.A. GLENOID DRILL SMALL/STD/LARGE; GLENOID DRILL - SMALL/STD/LARGE

Model Number 9013.75.230

Device Problem Mechanical Problem (1384)

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

Event Date 05/22/2023

Event Type  malfunction  

Event Description

During primary shoulder surgery performed on (b)(6) 2023, difficulty was encountered while implanting the std metalback glenoid (product code 1375.20.10, lot #2223647 - product not sold in the us) even after impacting it repeatedly.According to the received information, before implanting the metalback, the surgeon used the glenoid drill small/std/large (product code 9013.75.230, lot #20bh13y) to ream for the metalback's peg multiple times.Still, the metal back was sitting around 1mm off.Surgery got prolonged by 20 minutes due to the issue.The number of uses of instrument are unknown.It was reported that patient had severe osteoporotic bone.Event happened in australia.

Manufacturer Narrative

Checking the device history records of the involved lot #20bh13y, no pre-existing anomalies were found on the 110 pieces belonging to that lot #.This is the first and only complaint received on the involved lot #.We submit a final mdr as soon as the investigation is complete.

Manufacturer Narrative

Checking the device history records of the involved lot #20bh13y, no pre-existing anomalies were found on the 110 pieces belonging to that lot #.This is the first and only complaint received on the involved lot #.Further checking the manufacturing charts of the involved metalback belonging to lot #2223647, no pre-existing anomaly was found on the 51 components manufactured with the same lot #.According to our records, at least 36 out of 51 metalbacks with lot #2223647 and ster.2200314 have been implanted, and no complaint has been received on this lot #.Device analysis the glenoid drill involved in the complaint was returned to limacorporate for further analysis.Dimensional analysis performed on the device confirmed that it is compliant with the drawing specifics.Inspecting the cutting edges of the reamer it was found that they are worn and not sharp as expected.Visual inspection confirmed that some scratches are visible on these edges.Therefore, cutting edges of the returned glenoid drill are worn and torn, and it can be hypothesized that this contributed to the event.Indeed, it should be considered that: check of the manufacturing charts highlighted no anomalies on the instruments manufactured with lot #20bh13y and on metalbacks manufactured by lot #2223647; even if the number of uses of the involved instrument are unknown, the device was manufactured in 2020, serving the market for around 3 years; based on the performed analysis, the instrument was manufactured up to the specifics, but its edges were found to be blunt; we can draw the root cause of the event to the wear and tear of the instrument due to its multiple uses over the years.The blunt cutting edges prevent the instrument to function according to the intended use, determining a lower cutting efficiency for the device.In addition, the osteoporotic bone of the patient contributed to the difficulties encountered in drilling because the osteoporotic bone emphasizes the low cutting efficiency of this drill.Thus, 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 instruments belonging to product codes 9013.75.225 and 9013.75.230 is 0.10% (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 required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

Event Description

During a primary shoulder surgery performed on may 22nd, 2023, difficulty was encountered while implanting the std metalback glenoid (product code 1375.20.010, lot #2223647 - product not sold in the us) even after impacting it repeatedly.According to the received information, before implanting the metalback, the surgeon used the glenoid drill small/std/large (product code 9013.75.230, lot #20bh13y) to ream for the metalback's peg multiple times.Still, the metal back was sitting around 1mm off.Surgery got prolonged by 20 minutes due to the issue.The number of uses of the instrument are unknown.It was reported that patient had severe osteoporotic bone.Event happened in australia.

• Brand Name: GLENOID DRILL SMALL/STD/LARGE
• Type of Device: GLENOID DRILL - SMALL/STD/LARGE
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 17123581
• MDR Text Key: 317834789
• Report Number: 3008021110-2023-00074
• 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,Followup
• Report Date: 09/14/2023

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: 9013.75.230
• Device Lot Number: 20BH13Y
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2023
• 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