MAUDE Adverse Event Report: NEXTREMITY SOLUTIONS, INC. STRATUM FPS; PLATE

Catalog Number STRM-ST8-RS

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

If addtional information is provided that changes the outcome of the investigation, a follow-up report will be filed.

Event Description

Surgeon selected a stratum rs 8 hole plate strm-st8-rs.After placing the plate down on the foot he realized that the plate was to long for desired repair.While attempting to remove the plate one of the tines broke off.Surgeon decided to leave it in patient.

• Brand Name: STRATUM FPS
• Type of Device: PLATE
• Manufacturer (Section D): NEXTREMITY SOLUTIONS, INC.; 1195 polk drive; warsaw IN 46582
• Manufacturer (Section G): NEXTREMITY SOLUTIONS, INC.; 1195 polk drive; warsaw IN 46582
• Manufacturer Contact: travis christman ; 1195 polk drive; warsaw, IN 46582
• MDR Report Key: 12915258
• MDR Text Key: 281609945
• Report Number: 3009540749-2021-00039
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: STRM-ST8-RS
• Device Lot Number: 154667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female