MAUDE Adverse Event Report: ORCHID ANATOMIC RESECTION JIG

Model Number 9013.50.304

Device Problems Sticking (1597); Failure to Advance (2524)

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

Event Type  malfunction  

Manufacturer Narrative

The check of the manufacturing charts of the lot # involved did not show any anomaly on the 75 smr anatomic resection jigs (lot 2014aa134) manufactured with this lot #.We will send a final mdr once the investigation will be concluded.

Event Description

During surgery, pin could not pass through one of the holes of the smr anatomic resection jig, model# 9013.50.304, lot# 2014aa134.Surgery time extended of about 5 minutes, but no consequences for the patient have been reported since the surgeon was able to successfully conclude the surgery by cutting freehand.According to the info reported, after the sterilization it was possible to remove the stuck pin from the resection jig.Estimated number of usages of the pin involved in this issue: 10-20 times.Event happened in (b)(6).

Manufacturer Narrative

The check of the manufacturing charts of the lot # involved did not show any anomaly on the 75 smr anatomic resection jigs (lot 2014aa134) manufactured with this lot #.We received the jig and pin involved in the intra-op issue: as model# and lot# are not marked on the pin, and the complaint source could not provide model# and lot# of the pin, we could not check its manufacturing chart.By a visual check, the external surface of the pin is very damaged and rough, probably due to repeated (and maybe inaccurate) use of the pin.A functional check with the returned devices confirmed that, due to damage and slight deformation of the pin, the pin cannot pass through some of the holes of the resection jig.A dimensional check was also performed on the devices returned with following results: - male diameter of the pin: slight over-dimensioning (+0.03 mm), in addition an over-roughness due to damage of the external surface was also detected - female diameters (holes) of the jig: compliant to drawing specifications for 6 of the 7 holes of the jig, while the 7th has a slight under-dimensioning; but a functional check with a new undamaged pin and the returned jig confirmed that the new pin passes through all the holes of the jig.This confirms that the cause of the intra-op issue reported (seizure between pin and one hole of the jig) is the high damage and over-roughness of the pin external surface.No corrective actions planned for this specific case.The non-functionality between jig and pin is due to damage and over-roughness of the pin related to its repeated (and probably inaccurate) use during the previous surgeries where it was used.Lima corporate is aware of other 5 similar events with resection jigs model # 9013.50.304.For the cases where we received and could analyze the devices involved, the cause of the seizure between jig and pin was identified to be the 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 or slightly exceeding the maximum allowed (after damaging).In july 2016, after receiving similar complaints involving seizure of a pin into the resection jig 9013.50.304, the technical drawing of the jig was improved in order to slightly increase the holes diameter (minimum allowed: from dia.3.05 mm to dia.3.10 mm) and reduce the risk of intra-op seizure of the pin into the holes of the jig, even after an unexpected damage of the pin external surface.No similar events for the improved design of the resection jig were reported.Lima corporate will continue to monitor the market to promptly detect the possible recurrence of such issue.

Event Description

During surgery, pin could not pass through one of the holes of the smr anatomic resection jig, model# 9013.50.304, lot# 2014aa134.Surgery time extended of about 5 minutes, but no consequences for the patient have been reported since the surgeon was able to successfully conclude the surgery by cutting freehand.According to the info reported, after the sterilization it was possible to remove the stuck pin from the resection jig.Estimated number of usages of the pin involved in this issue: 10-20 times.Event happened in (b)(6).

• Brand Name: ANATOMIC RESECTION JIG
• Type of Device: ANATOMIC RESECTION JIG
• Manufacturer (Section D): ORCHID; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer Contact: giulio puppa puppa
• MDR Report Key: 6492886
• MDR Text Key: 73098709
• Report Number: 3008021110-2017-00028
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• 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
• 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