MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR - POSITIONING HANDLE FOR K-WIRE

Model Number 9013.75.301

Device Problems Failure To Adhere Or Bond (1031); Device-Device Incompatibility (2919)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

A final report will be submitted after complete investigation.

Event Description

During a shoulder replacement surgery, it was noted that the k-wire positioning handle (product code 9013.75.301, lot # 2015aa9b8) would not securely hold the inclination guide in place.Additionally, the anatomic resection jig (product code 9013.50.304, lot #2015aa054) did not accept a pin in one of its holes.No reported consequences for the patient.Event occurred in usa on (b)(6) 2016.

• Brand Name: SMR - POSITIONING HANDLE FOR K-WIRE
• Type of Device: SMR - POSITIONING HANDLE FOR K-WIRE
• 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: 6803518
• MDR Text Key: 83304743
• Report Number: 3008021110-2016-00137
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130642
• 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: 9013.75.301
• Device Lot Number: 2015AA9B8
• Was the Report Sent to FDA?: No
• 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