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

Model Number 9013.52.304

Device Problem Entrapment of Device (1212)

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, pin got stuck in the reverse resection jig while surgeon was starting the humeral head resection.After noticing the issue, surgery was successfully concluded performing the cutting freehand.Less than 10 minutes of prolonged surgery time was reported.Estimated number of uses of the instrument unknown.Event happened in (b)(6) on (b)(6) 2018.

• Brand Name: REVERSE RESECTION JIG
• 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, 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; IT
• MDR Report Key: 7345460
• MDR Text Key: 103165205
• Report Number: 3008021110-2018-00019
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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 a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.52.304
• Device Lot Number: 14AA458
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2018
• 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