MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR ANATOMIC RESECTION JIG

Model Number 9013.50.304

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2015

Event Type  malfunction  

Event Description

During surgery, the 3x80mm pin, could not pass through one of the holes of the smr anatomic resection jig.The problem occurred when the surgeon was securing the anatomic cutting block into the humerus.Surgery time was prolonged of 5 minutes with no consequences for the patient.The event occurred in australia.

Manufacturer Narrative

The check of the manufacturing charts of the lot # involved did not show any anomaly on the 75 smr resection jigs (lot 2014aa134) and the 601 pins (lot 2014aa103c) manufactured with these lot #.No other signaling was received on these lot #.We will receive the instruments involved and analyse them.

Manufacturer Narrative

The check of the manufacturing charts of the lot # involved did not show any anomaly on the (b)(4) smr resection jigs (lot 2014aa134) and the (b)(4) pins (lot 2014aa103) manufactured with these lot #.No other complaint was received on these lot #.The smr anatomic resection jig and the pins involved were returned to limacorporate.They underwent a dimensional check: no dimensional anomaly was detected on the pins and on the diameter of the seven (7) holes of the resection jig; two (2) holes out of seven (7) were found to be slightly oval.The functionality of each hole of the jig was tested with the two (2) pins: both pins could pass through each of the seven (7) holes of the jig.A slight resistance to the pin insertion was noticed in one (1) hole when used in combination with one (1) of the two (2) pins but even in this case the pin could pass through the hole; the second pin could go through the same hole with no difficulties.The jig and the pins are therefore functional.According to limacorporate post market surveillance data, a total of two similar complaint was received on a total of (b)(4) smr anatomic resection jig manufactured with the product code involved.No corrective actions have been planned.Limacorporate will continue to monitor the market to promptly detect the possible recurrence of such issue.

Event Description

It was reported that, during surgery, a 3x80mm pin could not pass through one of the holes of the smr anatomic resection jig; a second pin with the same lot # was able to pass through the same hole but with some difficulties.The problem occurred when the surgeon was securing the anatomic cutting block into the humerus.Surgery time was prolonged of 5 minutes with no consequences for the patient.The event occurred in (b)(6).

• Brand Name: SMR ANATOMIC RESECTION JIG
• Type of Device: SMR ANATOMIC RESECTION JIG
• 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: 4865367
• MDR Text Key: 6041954
• Report Number: 3008021110-2015-00026
• 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: Distributor,distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.50.304
• Device Lot Number: 2014AA134
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2014
• 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