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

Model Number 9013.52.304

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2016

Event Type  malfunction  

Manufacturer Narrative

The check of the dhr of the cutting guide involved did not show any anomaly on the 41 cutting jigs manufactured with the same lot # (2015aa037).This is the first and only complaint received on this lot number.We will receive the instrument involved and analyze it.We have also requested the product code and lot # of the wire involved.With this information we will perform a deeper analysis on this case and submit a final mdr.

Event Description

During a shoulder replacement surgery, when inserting the 3mm k-wire into the reverse cutting jig, the wire got stuck.The wire was cut and an alternative hole was used.Surgery time was extended of 10 minutes; no consequences for the patient were reported.Event occurred in (b)(6) on the (b)(6) 2016.

Manufacturer Narrative

The check of the dhr of the cutting guide involved did not show any anomaly on the 41 cutting jigs manufactured with the same lot # (2015aa037).From additional information, the pin involved is an allegra (competitor) pin.The involved smr reverse resection jig and the pin were returned to limacorporate.The competitor's pin was extracted from the resection jig.By a visual analysis, the pin surface is worn and damaged, probably due to its repeated use; this has probably contributed to the malfunction reported.The jig underwent a dimensional check: no dimensional anomaly was detected on the pin surface and on the diameter of the seven (7) holes of the resection jig; one of the holes has a diameter very close to the minimum allowed, this could have contributed to the malfunction reported.Nevertheless, the analysis performed shows that the device involved was released on the market in compliance to specifications.According to limacorporate post-market surveillance data, a total of six (6) similar complaint were received on a total of 1088 smr reverse resection jig manufactured (model # 9013.52.302-304-305).In two (2) out of six (6) cases, pins from other manufacturers were used in combination 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 six (6) 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 a shoulder replacement surgery, when inserting the 3mm k-wire into the reverse cutting jig, the wire got stuck.The wire was cut and an alternative hole was used.Surgery time was extended of 10 minutes; no consequences for the patient were reported.Event occurred in (b)(6) on the (b)(6) 2016.

• Brand Name: SMR REVERSE RESECTION JIG - DELTOPECTORAL APPROACH
• Type of Device: KWT, HSD
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; IT
• Manufacturer Contact: giulio puppa ; via nazionale, 52; villanova di san daniele, 33038 ; IT 33038
• MDR Report Key: 5580604
• MDR Text Key: 43771572
• Report Number: 3008021110-2016-00017
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• 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
• Is the Reporter a Health Professional?: No
• 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
• Patient Outcome(s): Hospitalization