MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHAFT ANGLED GLENOID REAMER; SHAFT FOR ANGLED GLENOID REAMER

Model Number 9013.75.355

Device Problem Material Fragmentation (1261)

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

Event Date 07/19/2023

Event Type  malfunction  

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #21bh05y, no pre-existing anomaly was found on the 61 devices manufactured with the same lot #.This is the first and only complaint received on this lot #.We submit a final mdr when the investigation is complete.

Event Description

During a primary smr reverse surgery performed on (b)(6) 2023, the smr shaft angled glen reamer (product code 9013.75.355, lot #21bh05y) broke during the course of the reaming because the reamer contacted the inferior retractor.It was reported that when removing the reamer shaft to reposition the retractor, the surgeon noticed that the reamer shaft was broken at the tip where the reamer attaches.According to the received information, trial phase showed that there was adequate bone implant contact.The surgery was then concluded successfully.Surgical time got extended by 15 minutes due to the issue.Event happened in australia.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #21bh05y, no pre-existing anomaly was found on the (b)(4) devices manufactured with the same lot #.This is the first and only complaint received on this lot #.Device analysis the instrument was returned for analysis.The returned shaft is missing the tip that broke during the surgery, that piece was not returned.On the shaft it is visible that the tip broke at its base.Considering that: · check of the manufacturing charts highlighted no anomalies on the components manufactured with lot #21bh05y; · during surgery the instrument got caught on a retractor, and the surgeon noticed the breakage upon repositioning; we can state that the event is not product related.The breakage is due to the shaft contacting the retractor.Pms data the smr shaft angled glenoid reamer (product code 9013.75.355) involved in the complaint belongs to v.02 of the instrument.According to our pms data, we can estimate the breakage rate of the instrument 9013.75.355 v.02 to be 0.30%.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 smr reverse surgery performed on (b)(6) 2023, the tip of the smr shaft angled glenoid reamer (product code 9013.75.355, lot #21bh05y) broke in the course of reaming.It was reported that the reamer contacted the inferior retractor.When removing the reamer shaft to reposition the retractor, the surgeon noticed that the shaft was broken at the tip where the reamer attaches.According to the received information, trial phase showed that there was adequate bone implant contact.The surgery was then concluded successfully.Surgical time got extended by 15 minutes due to the issue.The instrument was used approximately 6 times.Event happened in australia.

• Brand Name: SMR SHAFT ANGLED GLENOID REAMER
• Type of Device: SHAFT FOR ANGLED GLENOID REAMER
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 17377286
• MDR Text Key: 319989832
• Report Number: 3008021110-2023-00095
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K191746
• 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: 10/16/2023

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: 9013.75.355
• Device Lot Number: 21BH05Y
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/26/2023
• 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): Other