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

Model Number 9013.52.304

Device Problem Mechanical Jam (2983)

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

Event Date 03/24/2016

Event Type  malfunction  

Manufacturer Narrative

The check of the manufacturing charts of the lot # involved (2015aa037) did not show any anomaly on the 41 smr resection jigs manufactured with this lot #.The lot # of the pin involved is unknown.The smr reverse resection jig and the pin involved were returned to limacorporate.The pin was extracted from the resection jig; by a visual analysis the pin surface is worn and damaged due to its repeated use; due to the damage, its external surface is not perfectly circular.Both the pin (measured where less worn out) and the jig underwent a dimensional check: no dimensional anomaly was detected on the undamaged surface of the pin and on the diameter of the seven (7) holes of the resection jig.The functionality of each hole of the jig was tested with the pin involved: even if damaged, the pin could pass through each of the seven (7) holes of the jig.A slight resistance to the pin insertion was noticed in the only hole where the pin got stuck during surgery.The analysis performed shows that the devices involved were released on the market compliant to specifications, and that the damage of this single pin is the likely cause of the intra-op issue reported.According to limacorporate post market surveillance data, a total of (b)(4) similar complaints were received on a total of (b)(4) smr reverse resection jig manufactured with the product code involved.In (b)(4) cases out of (b)(4), pin 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 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 3x80mm pin got stuck into one of the holes of the smr reverse resection jig (product code 9013.52.304, lot # 2015aa037).No 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: 5871438
• MDR Text Key: 51954363
• Report Number: 3008021110-2016-00033
• 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

• Date FDA Received: 08/12/2016
• 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: 2015AA037
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2015
• 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