MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR GLENOID REAMERS AND DRILL SHAFT

Model Number 9013.75.350

Device Problem Connection Problem (2900)

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

Event Date 05/08/2015

Event Type  malfunction  

Event Description

When reaming the glenoid, the surgeon noticed that the reaming was eccentric, due to poor connection between the smr glenoid reamer and the power tool.The surgery was completed with the same instrument but it was slowed down.No consequences for the patient were reported.The event occurred in (b)(6).

Manufacturer Narrative

The check of the manufacturing charts of the lot # involved (2014aa540a) did not show any anomaly on the (b)(4) smr glenoid reamers and drill shaft manufactured with this lot #.No other signaling was received on this lot #.As soon as we receive the instrument involved, we will analyse it.Not received yet.

Manufacturer Narrative

The check of the manufacturing charts of the lot # involved (2014aa540a) did not show any anomaly on the 63 smr glenoid reamers and drill shaft manufactured with this lot #.No other complaint was received on this lot #.We received the instrument involved; the instrument underwent a dimensional check and no anomaly was detected.A functional test was also performed: the shaft was attached to a t-handle firstly and to a powered drill secondary (as allowed by the surgical technique) and in both cases the shaft was functional and no toggle could be seen.According to our analysis the instrument is fully functional and we don't know why the surgeon notice an eccentric reaming intra-operatively.According to limacorporate post market surveillance data, this is the first and only similar complaint received on the product code involved, on a total of 235 smr glenoid reamers and drill shaft manufactured.No corrective actions have been planned.Limacorporate will continue to monitor the market to promptly detect the possible recurrence of such issue.

Event Description

When reaming the glenoid, the surgeon noticed that the reaming was eccentric, due to poor connection between the smr glenoid reamer and the power tool.The surgery was completed with the same instrument but it was slowed down.No consequences for the patient were reported.The event occurred in (b)(6).

• Brand Name: SMR GLENOID REAMERS AND DRILL SHAFT
• Type of Device: SMR GLENOID REAMERS AND DRILL SHAFT
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, italy (udine) 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, italy (udine) 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 4868018
• MDR Text Key: 6058974
• Report Number: 3008021110-2015-00024
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.75.350
• Device Lot Number: 14AA540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2014
• 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