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

Model Number 9013.50.304

Device Problem Mechanical Jam (2983)

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

Event Date 09/22/2015

Event Type  malfunction  

Manufacturer Narrative

The preliminary check of the dhr of the anatomic cutting guide involved did not show any pre-existing anomaly.No other complaints were received on the lot # involved.We will receive the instrument involved and analyze it.Not received yet.

Event Description

During a smr shoulder replacement surgery performed on the (b)(6) 2015, the pin got stuck into the anatomic cutting guide.The surgeon was able to perform the humeral head resection and then remove entire pin/cutting block construct together.No impact on surgery.Event occurred in the us.

Manufacturer Narrative

The check of the dhr of the anatomic cutting guide involved did not show any pre-existing anomaly on the 58 pieces manufactured with lot # 14aa457.Although initially it was told that the instruments involved (anatomic cutting guide + pin) would have been send back to lima hq, they were not returned to lima corporate and so it was not possible to conduct a deeper analysis on the device.According to lima corporate post market surveillance data, a total of 6 similar complaints were received on a total of 812 smr anatomic cutting guides manufactured with the model # (9013.50.304) involved.At the moment, we could analyze the affected pieces only for 2 of the 6 cases, and found no pre-existing anomalies in the instruments analyzed.According to these analysis, the "cold-welding" between pin and cutting guide was probably caused, after a certain number of uses, by a slight damage on the external surface of the pin (male taper), maybe due to its improper use, combined with the dimensions of the pin diameter - male taper - very near to the maximum allowed.In july 2016, after receiving similar complaints involving seizure of a pin into the cutting guide 9013.50.304, the technical drawing of this instrument was improved in order to slightly increase the holes diameter (from dia 3.05 mm to dia 3.1 mm) and reduce the risk of intra-op seizure of the pin into the holes of the cutting guide, even after a certain number of uses.Lima corporate will continue to monitor the market to promptly detect the possible recurrence of such issue.

Event Description

During a smr shoulder replacement surgery performed on the (b)(6) 2015, the pin got stuck into the anatomic cutting guide, model # 9013.50.304, lot # 14aa457.The surgeon was able to perform the humeral head resection and then remove entire pin/cutting block construct together.No impact on surgery / patient.Event occurred in the us.

• Brand Name: ANATOMIC RESECTION JIG
• Type of Device: ANATOMIC RESECTION JIG
• Manufacturer (Section D): LIMACORPORATE S.P.A.; 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, udine 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale, 52; villanova di san daniele, 33038 ; IT 33038 ; 2 945511
• MDR Report Key: 5213134
• MDR Text Key: 31202348
• Report Number: 3008021110-2015-00048
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• 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
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.50.304
• Device Lot Number: 2014AA457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2014
• 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