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

Model Number 9013.52.304

Device Problems Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

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

Event Date 03/21/2016

Event Type  malfunction  

Manufacturer Narrative

The check of the manufacturing charts of the lot # involved (#2014aa458) did not show any anomaly on the (b)(4) smr resection jigs manufactured with this lot #.The pin involved is an allegra (competitor) pin.The smr reverse resection jig was returned to limacorporate.The competitor's pin was extracted from the resection jig, that underwent a dimensional check: no dimensional anomaly was detected on the diameter of the seven (7) holes of the resection jig.According to limacorporate post market surveillance data, a total of five (5) similar complaints were received on a total of (b)(4) smr reverse resection jig manufactured (product codes 9013.52.304-305).In two (2) cases out of five (5), pins from other manufacturers were used with limacorporate resection jigs; limacorporate ifu report that "the components forming original limacorporate systems must be rigorously coupled following the given indications.The use of single components, or components belonging to other systems, are subject to the approval by limacorporate.The manufacturer and the dealer are not liable for possible coupling incompatibility." in may 2016, after receiving similar complaints involving seizure of a lima pin into the resection jig 9013.52.304, the technical drawing of the smr reverse resection jig was modified in order to slightly increase the holes diameter and reduce the risk of intra-op seizure of the pin into the holes.The resection jigs involved in all (b)(4) complaints registered, were manufactured before this improvement.Limacorporate will continue to monitor the market to promptly detect the possible recurrence of this issue and assess the effectiveness of the corrective action performed.

Event Description

During surgery, a competitor's pin got stuck into one of the holes of the smr reverse resection jig (product code 9013.52.304, lot #2014aa458).The surgery was completed by inserting a limacorporate pin into a different hole of the jig.Surgery time extended of 10 minutes, no other reported consequences for the patient.The event occurred in (b)(6).

• Brand Name: SMR REVERSE RESECTION JIG
• Type of Device: SMR REVERSE 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: 6033135
• MDR Text Key: 57629455
• Report Number: 3008021110-2016-00034
• 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

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: 9013.52.304
• Device Lot Number: 2014AA458
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2014
• 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