MAUDE Adverse Event Report: LIMACORPORATE SPA SMR - GLENOSPHERE IMPACTOR; GLENOSPHERE IMPACTOR-EXTRACTOR

Model Number 9013.74.141

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 04/28/2020

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot #16aa00n, no pre-existing anomaly was detected.We will receive the instrument back to hq for investigation.We will submit a final mdr once the investigation will be concluded.

Event Description

Intra-operative issue occurred during smr reverse surgery on (b)(6) 2020.Surgeon was not satisfied of the glenosphere positioning, therefore decided to reposition it.When surgeon applied the glenosphere extractor code (b)(4) - lot #16aa00n, the instrument got stucked, avoiding glenosphere removal.Luckily there was a second set available and surgeon was able to complete the surgery.The event prolonged the surgery of 20 minutes.Event occurred in (b)(6).

Manufacturer Narrative

By checking the dhr of the lot #16aa00n, no pre-existing anomaly was detected on 50 glenosphere impactors-extractors manufactured with this lot.The instrument was not returned to limacorporate for investigation, therefore it was not possible to perform any kind of analysis on the item involved in this issue.The only information we have, is the visual analysis performed by the complaint source, who reported "upon examining the instrument after the surgery there were no obvious damage however as in the surgery the piece did not reach the thread of the barrel." at this stage, we are not able to investigate the root cause of the event.Considering the compliance of the manufacturing chart and the lack of obvious damage to the instrument (as reported by the complaint source), we cannot judged this case as product related.Pms data: according to our pms data, occurrence rate of this kind of intra-operative event (instrument 9013.74.141 gets stuck in the glenosphere) is 0.8%.This value is strongly overestimated because it does not take into account the number of uses of each instrument.No corrective action was implemented due to this specific event.Limacorporate will keep the market monitored.

Event Description

Intra-operative issue occurred during smr reverse surgery on (b)(6) 2020.Surgeon was not satisfied of the glenosphere positioning, therefore decided to reposition it.When surgeon applied the glenosphere extractor code 9013.74.141 - lot #16aa00n, the instrument got stucked, avoiding glenosphere removal.Luckily there was a second set available and surgeon was able to complete the surgery.The event prolonged the surgery of 20 minutes.Event occurred in australia.

• Brand Name: SMR - GLENOSPHERE IMPACTOR
• Type of Device: GLENOSPHERE IMPACTOR-EXTRACTOR
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 10023455
• MDR Text Key: 200453053
• Report Number: 3008021110-2020-00029
• 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: 11/02/2020

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: 9013.74.141
• Device Lot Number: 16AA00N
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/05/2020
• Supplement Dates Manufacturer Received: 05/04/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization