MAUDE Adverse Event Report: LIMACORPORATE S.P.A. GLENOID DRILL PEG S; GLENOID DRILL S

Model Number 9013.79.500

Device Problems Break (1069); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 06/19/2020

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot #18ag0aw, no pre-existing anomaly was detected on all the components manufactured with this lot #.This is the first and only complaint received on this lot number.We will submit a final mdr once the investigation will be completed.

Event Description

During primary shoulder surgery, the smr tt hybrid glenoid could not get fully seated.According to the complaint source, the surgeon made several impaction attempts and retraced all of the technique steps.During the second attempt, surgeon still could not get the glenoid seat.In pulling the glenoid out, the poly broke and the peg was taken out separately.At the third attempt, the glenoid was correctly seated.Two glenoid drill peg s (product code 9013.79.500, lot# 18ag0aw) were used during surgery to prepare the glenoid.Surgery prolonged of 30 minutes.Event happened in the us.

Event Description

During primary shoulder surgery performed on (b)(6) 2020, the smr tt hybrid glenoid could not get fully seated.According to the complaint source, the surgeon made several impactions attempts and retraced all of the technique steps.During the second attempt, surgeon still could not get the glenoid to seat.In pulling the glenoid out, the polyethylene broke, and the peg was taken out separately.At the third attempt, the glenoid was correctly seated.Two glenoid drill peg s (product code 9013.79.500, lot number 18ag0aw) were used during surgery to prepare the glenoid.No further information was provided on the involved trialed implants.Specifically, their lot numbers were not retrieved.One of the two involved pegs was returned, and it was confirmed to be of #s (it belongs to sub-product code 1379.14.150).Surgery prolonged of 30 minutes.Event happened in the united states.

Manufacturer Narrative

Investigation by checking the manufacturing charts of the involved lot number 18ag0aw, no pre-existing anomaly was found on a total of 51 items manufactured with the same lot number.This is the only complaint received on this lot number.No check on manufacturing charts can be performed for the pegs since their lot numbers are not known.The two drills and one of the pegs have been received by limacorporate for further analysis.X-rays analysis the post-operative x-rays have been shared with the medical expert, and his evaluation is summarised in following comments: "the surgeon made some mistakes with the instrumentation, otherwise this cannot be explained.If he really was able to fit in the trial component properly, then there must have been a proper preparation of the bone bed meaning correct drill holes in location and size/depth etc.What probably happened is that there was a slight angling during final insertion which may have led to improper engagement of the superior and lower pe small pegs which prevented the component from getting it seated.Another possibility: drill size of the peg and trial size were not what he finally implanted.The final radiographs look okay in terms of position and alignment.So, in the end, no harm is done.Reason remains finally unclear." analysis on returned devices a dimensional analysis was performed on the returned devices: it confirmed that the drills and the peg were manufactured up to specifications.No out-of-tolerance measures were found, only a slight discrepancy has been detected on a single dimension, but this is a consequence of the several attempts to seat the glenoid.Therefore, considering that: - check of manufacturing charts highlighted no anomalies on the total number of components manufactured with lot number 18ag0aw.- according to the medical expert's opinion, the surgeon made some mistakes with the instruments (there was a slight angling during final insertion, or the drill size of the peg and the trial size were not what the surgeon finally implanted).- dimensional analysis performed on returned items confirmed that the slight discrepancy detected is a consequence of the several attempts to seat the glenoid.We can state that the event was not product related.An improvement of the smr tt hybrid glenoid drill 9013.79.500 was introduced to reduce the risk of incorrect implant seating, especially in cases of sclerotic bone.This activity was initiated as a preventive action in 2018.The new instrument is currently available on the market.Pms data according to our pms data, we can estimate the occurrence rate of intra-operative similar issues - using the instrument glenoid drill peg s - to be around 0.04%.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.

• Brand Name: GLENOID DRILL PEG S
• Type of Device: GLENOID DRILL S
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 10756019
• MDR Text Key: 231455058
• Report Number: 3008021110-2020-00087
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K163397
• 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: 04/30/2024

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: 9013.79.500
• Device Lot Number: 18AG0AW
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2024
• 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