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

Catalog Number	MS-SSL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned driver shafts exhibited the reported condition.Device history records related to the event were reviewed.There were no non-conformances detected through the device history record review.A follow-up report will be filed if additional information is provided in the future.
Event or Problem Description
It was reported that during a surgery using the msp metatarsal shortening system, the screwdriver tip broke off into the head of the screw.A second kit was opened to use the driver.The second driver broke in the same way as the first.Both fractured driver tips were removed from the patient.A third driver was used to complete the surgery.No patient complications were reported.

• Brand Name: MSP METATARSAL SHORTENING SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): NEXTREMITY SOLUTIONS; 210 north buffalo street; warsaw IN 46580
• MDR Report Key: 9482754
• Report Number: 3009540749-2019-00022
• Device Sequence Number: 13552895
• Product Code: LXH
• UDI-Device Identifier: 00817701020097
• UDI-Public: 00817701020097
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K140724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2019

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 Catalogue Number: MS-SSL
• Device Lot Number: 168417318A, 168409518A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1