MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR - REVERSE RESECTION JIG DPA; REVERSE RESECTION JIG - DELTOPECTORAL APPROACH

Model Number 9013.52.304

Device Problems Fitting Problem (2183); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No anomalies which could have contributed to the issue by checking the manufacturing charts of the lot # of instrument involved.(b)(4).We will receive the instruments involved and analyze them before submitting our final report.

Event Description

During a smr reverse procedure, some smr pins did not fit well into reverse resection jig.One pin was temporarily jammed in the jig.Surgery time prolonged by 2-5 minutes, no impact on patient.The event occurred in (b)(6).

Manufacturer Narrative

No anomalies which could have contributed to the event by checking the manufacturing charts of the lot # of instrument involved.The smr reverse resection jig was returned to lima corporate together with several pins used during surgery.Pins and the jig underwent a dimensional check: no dimensional anomaly was detected on all the pins and on the diameter of the seven (7) holes of the resection jig.The functionality of each hole of the jig was tested with all pins: each pin could pass through each of the seven (7) holes of the jig; a slight resistance to the pin insertion was noticed in some of the holes but the functionality of the instruments is not compromised.According to lima corporate post market surveillance data, a total of (b)(6) similar complaints were received on a total of 1071 smr reverse resection jig manufactured (product codes 9013.52.304-305).In (b)(4) cases out of (b)(4), pins from other manufacturers were used with lima corporate resection jigs; lima corporate ifu report that "the components forming original lima corporate 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 lima corporate.The manufacturer and the dealer are not liable for possible coupling incompatibility." in may 2016 the technical drawing of the smr reverse resection jigs 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.Lima corporate 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 a smr reverse procedure, some smr pins did not fit well into reverse resection jig.One pin was temporarily jammed in the jig.Surgery time prolonged by 2-5 minutes, no impact on patient.The event occurred in (b)(6).

• Brand Name: SMR - REVERSE RESECTION JIG DPA
• Type of Device: REVERSE RESECTION JIG - DELTOPECTORAL APPROACH
• 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: 5156824
• MDR Text Key: 28927324
• Report Number: 3008021110-2015-00043
• 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,Followup
• Report Date: 09/18/2015

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: 14AA458
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/18/2015
• Initial Date FDA Received: 10/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/06/2016
• 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
• Patient Outcome(s): Hospitalization