MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR - GLENOSPHERE EXTRACTOR

Model Number 9013.74.145

Device Problems Material Twisted/Bent (2981); Difficult or Delayed Separation (4044)

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

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot #19aq1t4, #18aq1bm, #18aq13e, and #19aq1t5 no pre-existing anomalies were detected on all the components manufactured with these lot #s.We will submit a final report once the investigation will be completed.

Event Description

Intra-operative event occurred during a shoulder surgery for infection performed on (b)(6) 2020 reported to fda as complaint (b)(4).During the surgery there were some difficulties to disengage the connector from the baseplate.Three glenosphere extractors were trialed during the surgery: smr - glenosphere extractor (product code 9013.74.145, lot #19aq1t4), smr - glenosphere extractor (product code 9013.74.145), lot #unclear (the complaint source reported the external part to be from lot #19aq1t4, the internal part from lot #19aq1t5), · smr - glenosphere extractor (product code 9013.74.145), lot #unclear (the complaint source reported the external part to be from lot #18aq1bm, the internal part from lot #18aq13e).They all broke in a similar way: the plunger bent inside the extractors and did not come out.The surgical time was prolonged of about 30 minutes due to this issue.The surgery was positively completed by using other instruments.Event happened in the us.

Event Description

Intra-operative event occurred during a shoulder surgery for infection (event reported to fda as complaint (b)(4) - mfr 3008021110-2020-00056) performed on (b)(6) 2020.During the surgery there were some difficulties to disengage the connector from the metal back baseplate.Three glenosphere extractors were trialed during the surgery: smr - glenosphere extractor (product code 9013.74.145, lot number 19aq1t4).Smr - glenosphere extractor (product code 9013.74.145), lot number unclear (the complaint source reported the external part to be from lot number 19aq1t4, the internal part from lot number 19aq1t5).Smr - glenosphere extractor (product code 9013.74.145), lot number unclear (the complaint source reported the external part to be from lot number 18aq1bm, the internal part from lot number 18aq13e).They all broke in a similar way: the plunger bent inside the extractors and did not come out.According to the information reported, the surgical time was prolonged of about 30 minutes due to this issue.Eventually, the surgery was positively completed by using other instruments available in the or.The patient is a male, 66 years old, with no prior case of infection, according to the information provided.Event happened in united states.

Manufacturer Narrative

Investigation: by checking the dhr of the lot numbers 19aq1t4, 18aq1bm, 18aq13e, and 19aq1t5 no pre-existing anomalies were detected on all the components manufactured with these lot numbers.Instrument analysis: only the explants were available to be returned to hq for further analysis.According to the information received by the complaint source, the inability to break the taper between the baseplate and connector, causing the extractors to break and increase the case time was the only complaint that was made.The internal inspections of the explants highlighted that the most likely cause of the breakage is the presence of fretting between the parts connected that could have caused the difficulty in disengagement.Therefore, since: 1.No anomalies were found out by checking the manufacturing charts of the lot numbers involved, and.2.The internal analysis led to the identification of fretting as the as the most likely cause of the breakage of the instruments, we can suppose that the event could not be due to inherent problems of the products.Pms data: according to our pms data, we can estimate the breakage rate of the instrument smr - glenosphere extractor to be around 0,19% (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 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.This is a final mdr.

• Brand Name: SMR - GLENOSPHERE EXTRACTOR
• Type of Device: GLENOSPHERE EXTRACTOR
• 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: 10453808
• MDR Text Key: 207390365
• Report Number: 3008021110-2020-00057
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

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: 9013.74.145
• Device Lot Number: 19AQ1T4
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 06/26/2023
• 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): Hospitalization