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 Mechanical Jam (2983)

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

Event Date 10/13/2023

Event Type  malfunction  

Event Description

During a primary shoulder surgery performed on october 13th, 2023, the 2.5mm k-wire got caught inside the smr shaft angled glen reamer (product code 9013.75.355, lot #21bh07d) upon reaming and would not pass through the shaft.Initially, the k-wire was able to move freely.The surgeon decided to stop reaming for the implant and proceeded with peg reaming before implanting.The definitive glenoid was successfully implanted.Number of uses of the shaft is unknown.Surgical time got extended by 15 minutes due to the issue.It was reported that patient's bone was hard.Event happened in australia.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #21bh07d, no pre-existing anomaly was found on the 16 devices manufactured with the same lot #.We submit a final mdr when the investigation is complete.

Event Description

During a primary shoulder surgery performed on (b)(6) 2023, the 2.5mm k-wire got caught inside the smr shaft angled glen reamer (product code 9013.75.355, lot #21bh07d) upon reaming and would not pass through the shaft.Initially, the k-wire was able to move freely.The surgeon decided to stop reaming for the implant and proceeded with peg reaming before implanting.The definitive glenoid was successfully implanted.Number of uses of the shaft is unknown.Surgical time got extended by 15 minutes due to the issue.It was reported that patient's bone was hard.It was confirmed that the angled glenoid reamer and the shaft stopper ring were used in combination with the shaft.Event happened in australia.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #21bh07d, no pre-existing anomaly was found on the 16 devices manufactured with the same lot #.Device analysis: visual inspection confirmed that tines of the tip are bent.The instrument is intended to be used in combination with the plastic sleeve of the chosen slope, the glenoid reamer and the stopper ring: the complaint source confirmed that the instrument was used according to the surgical technique.A functional analysis was performed using a k-wire and it confirmed that the instrument's tip is bent as the k-wire cannot slide inside the instrument as intended.A second functional test had been performed using the k-wire and a glenoid reamer belonging to the product code 9013.75.356: it proved that the shaft can be coupled with the glenoid reamer, but the k-wire cannot slide inside as tines of the instrument are tilted.It should be considered that the torsion or bending of the tip's tines occurs during the use of the instrument.It was reported that patient's bone was hard.According to the surgical technique "in case of hard/sclerotic bone surface, the initial glenoid drill (product code 9013.75.121) can be optionally used to prepare the glenoid seat for reaming".To conclude: check of the manufacturing charts highlighted no anomalies on instruments manufactured with lot #21bh07d; the visual inspection and functional tests confirmed that the instrument's tip is bent, and the k-wire cannot slide inside it as intended; it was reported that patient's bone was hard, and the surgical technique suggests preparing the glenoid seat for reaming using the initial glenoid drill (product code 9013.75.121) in case of hard/sclerotic bone surface; a definitive root cause cannot be determined for the event, still we can state that the event was not product related.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 occurrence rate of intra-operative malfunctioning of the instrument 9013.75.355 v.02 to be 1,2% (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 continues monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

• 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: 18085001
• MDR Text Key: 327541357
• Report Number: 3008021110-2023-00121
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9013.75.355
• Device Lot Number: 21BH07D
• Is the Reporter a Health Professional?: No
• 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