MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; ANATOMIC RESECTION JIG

Model Number	9013.50.304
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The check of the dhr of the lot # of resection jig involved (2014aa268) did not show any pre-existing anomaly on the 62 resection jigs manufactured with this lot #.No other complaint was received on this lot #.Model # and lot # of the pin involved are not available at the moment.We will receive the pieces involved (resection jig + pin) and submit a final mdr after analyzing them.
Event or Problem Description
Intra-operative issue: a pin got cold welded into one of the holes of the smr anatomic resection jig.Surgical time prolonged of 2 minutes.No consequences for the patient were reported.Event occurred in (b)(6).
Event or Problem 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.Event occurred in australia.
Additional Manufacturer Narrative
Investigation: 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, resulted in having the maximum diameter allowed.This feature, combined with the pin surface, which is worn, may have contributed to the reported malfunction.Two (2) of the seven (7) holes of the resection jig resulted to be slightly under-dimensioned.Nevertheless, a functional check was performed and the pin could pass through all the 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.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 recurrence of similar events.Pms data: 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 (product codes #9013.52.302-304-305).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.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 the effectiveness of the corrective action performed.Note: this is a final mdr.Please note that the conclusions and the pms data documented here were valid at the time of closure (2016).This final report was created to address the lack of the closing mdr report.

• Brand Name: SMR SHOULDER
• Common Device Name: ANATOMIC RESECTION JIG
• 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.; IT
• Manufacturer Contact: giulio puppa ; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 5740999
• Report Number: 3008021110-2016-00028
• Device Sequence Number: 225265
• Product Code: HSD
• UDI-Device Identifier: 08033390103862
• UDI-Public: 08033390103862
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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
• Operator of Device: Health Professional
• Device Model Number: 9013.50.304
• Device Lot Number: 14AA268
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2016
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown