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

Model Number 9013.50.304

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

As a preliminary analysis we checked the dhr of the anatomic cutting guide involved: no pre-existing anomaly detected on the (b)(4) instruments manufactured with lot # 2014aa457.We will submit a final report after complete investigation.

Event Description

During a smr shoulder replacement surgery performed on the (b)(6) 2016, the pin got stuck into the anatomic cutting guide, model # 9013.50.304, lot # 2014aa457.The surgery was completed by using a different pin in one of the other holes of the guide.No impact on surgery and on patient.Event occurred in the us.

• Brand Name: SMR - ANATOMIC RESECTION JIG
• Type of Device: SMR - ANATOMIC RESECTION JIG
• 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
• MDR Report Key: 6803394
• MDR Text Key: 83222025
• Report Number: 3008021110-2016-00140
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.50.304
• Device Lot Number: 2014AA457
• Was the Report Sent to FDA?: No
• Date Device Manufactured: 11/19/2014
• 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