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 Break (1069)

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

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot # 20bh01d, no pre-existing anomalies were detected on all the pieces manufactured with this lot #.We will submit a final mdr once the investigation will be completed.

Event Description

During shoulder surgery performed on (b)(6) 2020, the smr shaft angled glenoid reamer (product code 9013.75.355, lot# 20bh01d) broke.According to the information reported by the complaint source, surgeon was not sure whether the breakage has been due to a hard bone or to the reamer catching a retractor.The surgical time was extended of 1 minute and broken pieces were removed.Surgery was successfully completed.It was reported that the instrument was used about 5-10 times.Event happened in the us.

Event Description

During a shoulder surgery performed on (b)(6) 2020, the smr shaft angled glenoid reamer (product code 9013.75.355, lot# 20bh01d) broke.According to the information reported by the complaint source, surgeon was not sure whether the breakage has been due to a hard bone or to the reamer catching a retractor.The surgical time was extended of only 1 minute and the broken pieces were removed.Surgery was successfully completed.Estimated number of uses of the instrument: 5-10 times.Event happened in the us.

Manufacturer Narrative

By checking the dhr of the lot # 20bh01d, no pre-existing anomalies were detected on all the pieces manufactured with this lot #.We received some pictures of the broken pieces of the instrument involved.As reported by the complaint source, surgeon was not sure whether the breakage has been due to a hard bone or to the reamer catching a retractor.The product code involved in this complaint (9013.75.355 v00, shaft for angled glenoid reamer) was used on the market in controlled release phase.After receiving a total of 8 complaints from the market, technical investigation identified all the potential critical points related to the instrument geometry: a corrective action was put in place to increase the mechanical resistance of the shaft for angled glenoid reamer leading to a new version (01) of the instrument.Moreover, an additional note ("in case of hard/sclerotic glenoid bone surface, the initial glenoid drill can be optionally used to prepare the glenoid seat for reaming") in the relevant surgical technique related to the optional pre-drill step will be added.This is a final report.Limacorporate will continue monitoring the market to promptly detect any further similar issue.

• 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: 10990513
• MDR Text Key: 223184072
• Report Number: 3008021110-2020-00114
• Device Sequence Number: 1
• Product Code: MBF
• 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
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9013.75.355
• Device Catalogue Number: 9013.75.355
• Device Lot Number: 20BH01D
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other