MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL HEAD DIA. 46MM; KWT, HSD

Model Number 1322.09.460

Device Problem Packaging Problem (3007)

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

Event Date 02/05/2014

Event Type  Other  

Event Description

By the info received, there was a packaging issue with a smr humeral head during a surgery dated (b)(6) 2014.This device is packaged into a double (outer and inner) vacuumed pouch.In detail, it seems that the humeral head dropped out from the inner vacuumed pouch before opening it, as if the inner pouch was not sealed.The surgery has been completed without problems, by using another size of humeral head available in surgical room.The event occurred in (b)(6).

Manufacturer Narrative

We checked the work cycle of the humeral head involved, without finding any anomaly during the packaging phases of the device.A total of 49 humeral heads have been packaged with the lot # 201110126-1200007.Also, we know that 48 humeral heads with the above lot number have been implanted, and we did not receive any similar signaling.We will receive the package, and we will submit a follow-up mdr after analysis on it.

• Brand Name: SMR HUMERAL HEAD DIA. 46MM
• Type of Device: KWT, HSD
• Manufacturer (Section D): LIMACORPORATE S.P.A.; villanova di san daniele del friuli - ud 0000 ; IT 0000
• Manufacturer Contact: via nazionale 52; villanova di san daniele del friuli - ud 33038 ; 432945511
• MDR Report Key: 3704375
• MDR Text Key: 4333669
• Report Number: 3008021110-2014-00002
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/07/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 1322.09.460
• Device Lot Number: 201110126-1200007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2014
• Initial Date FDA Received: 03/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1