MAUDE Adverse Event Report: LIMACORPORATE SPA REVERSE RESECTION JIG - DELTOPECTORAL APPROACH

Model Number 9013.52.304

Device Problems Mechanical Problem (1384); Retraction Problem (1536)

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 (2015aa037) did not show any anomaly on the 41 smr resection jigs manufactured with this lot #.As lot# was instead not readable on the pin, we could not check its related manufacturing chart.Both the pin and the reverse resection jig involved in the intra-op issue were returned to lima corporate.By a visual check, the external surface of the lima pin - broken in two pieces and with a deformed shape - appears to be very damaged and rough, probably due to repeated (and maybe inaccurate) use of the pin itself.A functional check with the returned devices confirmed that the pin cannot pass through some of the holes of the resection jig.A dimensional check was then performed on both the devices returned with the following results: male diameter of the pin: diameter of the pin was found to be compliant to specifications.No dimensional anomalies on its diameter, even if its external surface is damaged (rough) and deformed as reported above; female diameters (holes) of the reverse resection jig: on the left side, 6 out of the 7 holes of the jig found to be compliant to drawing specifications, while the 7th resulted to be slightly oval and slightly under-dimensioned (max deviation -0.021 mm).On the right side, all the 7 holes were found to be compliant.Likely cause for the intra-op seizure reported is the mix of a very damaged external surface of the pin (probably due to its repeated and maybe inaccurate use) and the found under-dimensioning of the hole on the left side of the resection jig; in fact, the pin was stuck on the hole for which the slight dimensional anomaly was detected.In addition, despite the slight dimensional anomaly of one of the holes in the resection jig, an undeformed pin can freely pass through all the jig holes, including the under-dimensioned one: this confirms that the damage/deformation of the pin external surface is the root cause of the seizure.No corrective action for this specific case.After receiving previous similar complaints, in may 2016 the technical drawing of the smr reverse resection jig was adjusted to slightly increase the holes diameter of the jig and therefore further reduce the intra-op risk of seizure of the pin into the jig holes, in case that the external surface of the pin is very damaged.For the similar complaints where we could analyze the affected pieces, the strongly damaged external surface of the pin was found to be the cause of the seizure between pin and jig.In all these cases, no adverse effects for patients were reported.All the resection jigs involved in all the similar complaints reported were manufactured before the drawing 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

A 3 x 80 mm lima pin got stuck in the reverse resection jig while preparing to cut the humeral head.According to the info reported, surgeon did still use the same jig to perform the humeral head resection, but it was necessary to cut the pin as it was not possible to remove the resection jig in other way.Surgery time extended of 5 minutes.Estimated number of uses of the instrument unknown.Event happened in (b)(6) on (b)(6) 2017.

• Brand Name: REVERSE RESECTION JIG - DELTOPECTORAL APPROACH
• Type of Device: REVERSE RESECTION JIG - DELTOPECTORAL APPROACH
• Manufacturer (Section D): LIMACORPORATE SPA
• MDR Report Key: 7548107
• MDR Text Key: 109898332
• Report Number: 3008021110-2017-00089
• 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: 2015AA037
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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