MAUDE Adverse Event Report: MIAMI DEVICE SOLUTIONS MULTIUSE SCREW, Ø2.7MM X L18MM

Model Number	MDS1002M18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Missing Value Reason (3192)
Date of Event	01/11/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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: MULTIUSE SCREW, Ø2.7MM X L18MM
• Common Device Name: MULTIUSE SCREW, Ø2.7MM X L18MM
• Manufacturer (Section D): MIAMI DEVICE SOLUTIONS; 7620 nw 25th st; unit 3; miami beach FL 33122
• MDR Report Key: 7230911
• Report Number: 3009222247-2018-00004
• Device Sequence Number: 13762334
• Product Code: HWC
• UDI-Device Identifier: 10812269022092
• UDI-Public: (01)10812269022092(10)BDKW9XH
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K161292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/05/2018

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
• Operator of Device: Physician
• Device Model Number: MDS1002M18
• Device Catalogue Number: MDS1002M18
• Device Lot Number: BDKW9XH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR