MAUDE Adverse Event Report: LIMACORPORATE SPA SMR- SMALL-R BONE GRAFT CUTTER

Model Number 9013.75.443

Device Problem Bent (1059)

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

Event Date 09/16/2017

Event Type  malfunction  

Manufacturer Narrative

No pre-existing defects were found by checking the manufacturing charts of lot# 2016aq0jp on the lot# involved on a total of 15 graft cutters manufactured with this lot#.We will send a final mdr once the investigation will be completed.

Event Description

Intra-operative malfunction of the smr - graft cutter, model # 9013.75.443, lot# 2016aq0jp.According to the info reported, when the graft cutter was introduced into the native humeral head, the blade bent.Estimated number of uses of the instrument: 7/8.Event happened in (b)(6).

Event Description

During a shoulder surgery performed on (b)(6) 2017, the blade of the bone graft cutter (product code 9013.75.443, lot 16aq0jp) bent when using the instrument on native humeral head - autograft.No reported consequences for the patient.This event occurred in italy.

Manufacturer Narrative

No pre-existing defects were found by checking the manufacturing charts of lot n.16aq0jp on a total of 15 graft cutters manufactured with this lot number.The graft cutter has a hook with a blade; the blade allows to take the bone graft and then graft it into the glenoid bone.Complaints monitoring and analysis highlighted that the root cause of breakage/bending of the graft cutter blades is related to an incorrect use of the cutters.Therefore, in 2017, limacorporate decided to update the surgical technique to give additional instructions on how to correctly use the cutter in order to avoid improper use (blade forced to come out when the instrument is not rotating) and to remind the importance of a careful use on allograft.In addition, a specific note was added in the surgical technique, to underline that the graft cutter is to be used on cancellous bone only (lower density bone).As a further corrective action, a new version of the graft cutter (v.02) was introduced.The improved design of the blade in v.02 graft cutters allowed to further increase its mechanical strength and further reduce the risk of its deformation during use.The reinforced blade (v.02 instrument) has been introduced on the market since september 2017.Nevertheless, we would like to underline that the internal functional tests on the v.01 instruments showed good mechanical resistance of the v.01 if the cutter is used properly (i.E.Blade comes out gradually from the sleeve after putting in rotation the cutter).Following the corrective action introduced, limacorporate decided to switch the v.01 graft cutters to v.02, when they naturally return to internal warehouses.Pms data six intra-operative complaints involving the bending of the graft cutters blade were reported to limacorporate (including the one object of this report).One of these complaints about bending of the blade, involved the last version of the graft cutter (v.02) and was attributed to patient's hard bone.Limacorporate is also aware of a total of 3 complaints about the breakage of the graft cutter blades.All three involved v.01 graft cutters and occurred during use on allograft.No serious intra-operative complications were ever reported as a consequence of the reported complaints limacorporate will keep monitored the market to confirm the effectiveness of the above corrective actions.

• Brand Name: SMR- SMALL-R BONE GRAFT CUTTER
• Type of Device: BONE GRAFT CUTTER
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 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, udine 33038 ; IT 33038
• MDR Report Key: 6903423
• MDR Text Key: 89504268
• Report Number: 3008021110-2017-00091
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K161120
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.75.443
• Device Lot Number: 16AQ0JP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/10/2022
• 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