MAUDE Adverse Event Report: DEPUY MITEK INC. DEPUY MITEK; RIGIDIFIX BIOCRYL BTB CROSS PIN

Catalog Number 210815

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/29/2018

Event Type  Injury  

Event Description

Portion of cross pin broke off and was retained in the pt's knee.X-rays confirmed, surgeon elected to leave the porton that had broken off versus removing.

• Brand Name: DEPUY MITEK
• Type of Device: RIGIDIFIX BIOCRYL BTB CROSS PIN
• Manufacturer (Section D): DEPUY MITEK INC. ; raynham MA 02767
• MDR Report Key: 7665752
• MDR Text Key: 113458058
• Report Number: MW5078275
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 210815
• Device Lot Number: L705449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other