MAUDE Adverse Event Report: MIAMI DEVICE SOLUTIONS LOCKING CAP, 2.7T

Model Number MDS100301L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Missing Value Reason (3192)

Event Date 01/11/2018

Event Type  Injury  

Manufacturer Narrative

Weight is unknown.Investigation: visual inspection of the subject device only revealed normal signs of wear and tear.Review of the dhr and ncr files was conducted and there were no findings that could have contribute to this complaint.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The operating surgeon reported that removal of the subject device and accompanying implants had been scheduled due to crepitus of the fpl tendon.The original surgery took place on (b)(6) 2017.The removal procedure was completed on (b)(6) 2018 with no complications reported.All implants were intact and returned to the manufacturer for evaluation.

• Brand Name: LOCKING CAP, 2.7T
• Type of Device: LOCKING CAP, 2.7T
• Manufacturer (Section D): MIAMI DEVICE SOLUTIONS; 7620 nw 25th st; unit 3; miami beach FL 33122
• Manufacturer Contact: anderson giraldo ; 7620 nw 25th st. unit 3; mimai beach, FL 33122 ; 3057225310
• MDR Report Key: 7230769
• MDR Text Key: 98669612
• Report Number: 3009222247-2018-00003
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10812269021767
• UDI-Public: (01)10812269021767(10)BDK2JSF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: MDS100301L
• Device Catalogue Number: MDS100301L
• Device Lot Number: BDK2JSF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR