MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR GLENOID REAMER S-R/S

Model Number 9013.75.160

Device Problem Dull, Blunt (2407)

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

Event Type  malfunction  

Manufacturer Narrative

The check of the dhr of the first lot # involved (14aa342) showed no dimensional / functional anomalies on the (b)(4) pieces placed on the market with this lot #.The check of the dhr of the 2nd lot # involved (14aa344) showed no dimensional / functional anomalies on the (b)(4) pieces placed on the market with this lot #.We will submit a final mdr after completing the investigation on this case.Not yet received.

Event Description

Intra-operative small issue involving a small smr-glenoid reamer (product code # 9013.75.160, lot # 14aa342) and a smr-glenoid reamer std (product code # 9013.75.165, lot#14aa344).Surgeon was reaming the small glenoid base plate at that time when he noticed that the reamers were blunt.Surgical time was extended by 5 minutes; the surgery was successfully completed by the surgeon using the blunt reamers.Patient outcome was not impacted.Event occurred in (b)(6).

Manufacturer Narrative

The check of the dhr of the lot # involved (14aa342) did not show any pre-existing anomaly on the 54 smr glenoid reamers released on the market with lot #14aa342 and on the 37 glenoid reamers released on the market with lot #14aa344.The reamer with lot# 14aa344 was the only one received by lima corporate.Visual analysis of the reamer confirmed that the reamer cutting edge is blunt.A technical analysis of the device highlighted that the cutting edge was beadblated and chrome coating was applied on it; beadblasting and chrome coatings applied to the cutting edge can reduce the edge sharpness and lead to reamer bluntness.In september 2015, before receiving this complaint, lima corporate updated the technical drawings of the reamers to specify that beadblasting and chrome coating must not be applied on the cutting edge of the reamers with product code 9013.75.160-165-170.Both the reamers involved in this complaint were manufactured in 2014, before introduction of this note in the technical drawing.A total of 4 similar complaints have been reported to lima corporate on blunt glenoid reamers with codes 9013.75.160-165-170 on a total of 1537 reamers sold ww, giving an occurrence rate of 0.26%.Lima corporate will continue monitoring the market in order to promptly detect any similar issue.

Event Description

Intra-operative small issue involving a small smr-glenoid reamer (product code # 9013.75.160, lot # 14aa342) and a smr-glenoid reamer std (product code # 9013.75.165, lot# 14aa344).Surgeon was reaming the small glenoid base plate at that time when he noticed that the reamers were blunt.Surgical time was extended by 5 minutes; the surgery was successfully completed by the surgeon using the blunt reamers.Patient outcome was not impacted.Event occurred in (b)(6).

• Brand Name: SMR GLENOID REAMER S-R/S
• Type of Device: SMR GLENOID REAMER S-R/S
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale, 52; villanova di san daniele, 33038 ; IT 33038 ; 2 945511
• MDR Report Key: 6095375
• MDR Text Key: 60092541
• Report Number: 3008021110-2016-00053
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.75.160
• Device Lot Number: 14AA342
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: 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