MAUDE Adverse Event Report: NEXTREMITY SOLUTIONS STRATUM FOOT PLATING SYSTEM; BONE SCREW

Catalog Number STRM-NL-3550ST

Device Problems Labelling, Instructions for Use or Training Problem (1318); Device Markings/Labelling Problem (2911); Inaccurate Information (4051)

Patient Problem Not Applicable (3189)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

While building a stratum foot plating system set, a sales representative selected a screw labeled as strm-nl-3550st and noticed the product in the package did not match the information on the label.The screw in the package was visibly a shorter length and a different type of screw.

• Brand Name: STRATUM FOOT PLATING SYSTEM
• Type of Device: BONE SCREW
• Manufacturer (Section D): NEXTREMITY SOLUTIONS; 210 north buffalo street; warsaw IN 46580
• Manufacturer (Section G): NEXTREMITY SOLUTIONS; 210 north buffalo street; warsaw IN 46580
• Manufacturer Contact: elise fox ; 210 north buffalo street; warsaw, IN 46580 ; 5743762062
• MDR Report Key: 9205308
• MDR Text Key: 167976827
• Report Number: 3009540749-2019-00009
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00817701022558
• UDI-Public: 00817701022558
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/27/2024
• Device Catalogue Number: STRM-NL-3550ST
• Device Lot Number: M1151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Date Manufacturer Received: 09/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1