MAUDE Adverse Event Report: NEXTREMITY SOLUTIONS, INC. MSP METATARSAL SHORTENING SYSTEM; SCREWDRIVER

Model Number	MS-SSR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during surgery the tip of the driver broke off inside the head of the screw and was not removed.The surgery was able to be completed successfully.No patient complications were reported.

• Brand Name: MSP METATARSAL SHORTENING SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): NEXTREMITY SOLUTIONS, INC.; 210 north buffalo street; warsaw IN 46580
• MDR Report Key: 8812319
• Report Number: 3009540749-2019-00006
• Device Sequence Number: 3205576
• Product Code: HXX
• UDI-Device Identifier: 00817701020103
• UDI-Public: 00817701020103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MS-SSR
• Device Lot Number: 168415217B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/22/2019
• 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: Other