MAUDE Adverse Event Report: LIMACORPORATE SPA SMR - ANATOMIC RESECTION JIG; SMR - ANATOMIC RESECTION JIG (KWT, HSD)

Model Number 9013.50.304

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 08/29/2018

Event Type  malfunction  

Manufacturer Narrative

By checking the manufacturing chart of the lot #15aq01d, no anomaly was found on a total of 70 smr - anatomic resection jigs manufactured with this lot.This is the first and only complaint received with this lot#.We will submit a final mdr once the investigation will be concluded.

Event Description

Intra-operative issue occurred during smr anatomic surgery performed on the (b)(6) 2019.During surgery, pin got stuck into the resection jig code 9013.50.304, lot #15aq01d.Surgeon completed the surgery resecting the humeral head in free hand and surgery was prolonged of 10 minutes.Event happened in (b)(6).

• Brand Name: SMR - ANATOMIC RESECTION JIG
• Type of Device: SMR - ANATOMIC RESECTION JIG (KWT, HSD)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: federica malvaso ; via nazionale52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 8975016
• MDR Text Key: 218739013
• Report Number: 3008021110-2019-00098
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9013.50.304
• Device Lot Number: 15AQ01D
• Date Manufacturer Received: 08/30/2019
• 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
• Patient Outcome(s): Hospitalization