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

Model Number 9013.52.304

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Insert (1316)

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 (#2014aa458) did not show any anomaly on the (b)(4) smr resection jigs manufactured with this lot #.We will submit a final mdr once the investigation will be completed.

Event Description

During surgery, a pin got stuck into one of the holes of the smr reverse resection jig (product code 9013.52.304, lot #2014aa458).The pin snapped and the end remained in the resection jig.Surgeon experienced great difficulty even trying to get pins through other holes in the cutting guide.No reported consequences for the patient.The event occurred in (b)(6).

Manufacturer Narrative

The check of the manufacturing charts of the lot # involved (#2014aa458) did not show any anomaly on the 56 smr resection jigs manufactured with this lot #.The smr reverse resection jig and pin were returned to limacorporate.Both instruments underwent a dimensional check.It was not possible to extract the pin tip from the jig, therefore it was not possible to measure the diameter of the hole where the pin got stuck.No dimensional anomaly was detected on the pin surface which, however, the pin resulted to have the maximum diameter allowed.This feature, combined with the pin surface which is worn, may have significantly contributed to the reported malfunction.Two (2) of the seven (7) holes of the resection jig resulted to be very slightly under-dimensioned (max deviation -0.027mm).Nevertheless, a functional check was performed and the pin could pass through all the free holes of the resection jig with no difficulty, with the exception of the hole involved where part of the pin is still stuck and the functional test was not possible.This is a confirmation that the root cause of the issue is the damage of the pin external surface after repeated use, probably combined with the fact that the pin diameter is at the maximum available.In (b)(6) 2016, after becoming aware of similar complaints involving a pin stuck into the resection jig, the technical drawing of the smr reverse resection jig was modified to slightly increase the holes diameter and thus to reduce the risk of reoccurrence of similar events.According to pms data, we are aware of ten (10) similar complaints on a total of 1088 smr reverse resection jigs manufactured before the corrective action described above (b)(4).In two (2) out of ten (10) cases, pins from other manufacturers were used in combination with limacorporate resection jigs even if limacorporate ifu advise that this must be avoided.For all the cases where we received the affected devices, the external surface of the pin was damaged compromising the functionality of the pin.No complaints received on the improved version of the instrument.Limacorporate will continue to monitor the market to promptly detect the possible recurrence of this issue and assess confirm the effectiveness of the corrective action performed.

Event Description

During surgery, a pin got stuck into one of the holes of the smr reverse resection jig (product code 9013.52.304, lot #2014aa458).The pin snapped and the end remained in the resection jig.Surgeon experienced great difficulty even trying to get pins through other holes in the cutting guide.No reported consequences for the patient.The event occurred in (b)(6).

• Brand Name: REVERSE RESECTION JIG - DELTOPECTORAL APPROACH
• Type of Device: REVERSE RESECTION JIG - DELTOPECTORAL APPROACH
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, 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: 6292330
• MDR Text Key: 66500675
• Report Number: 3008021110-2016-00069
• 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: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• 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: 2014AA458
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• 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