MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC MICA SCREW 3.0MM X 36MM FULLY THREADED STERILE; SCREW, FIXATION, BONE

Catalog Number	57S13036
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device remains implanted in patient.
Event or Problem Description
It was reported that the head of the screw snapped off during insertion into the toe.The surgeon was able to remove the head of the screw but the body remained in the patient.
Event or Problem Description
It was reported that the head of the screw snapped off during insertion into the toe.The surgeon was able to remove the head of the screw but the body remained in the patient.
Additional Manufacturer Narrative
The complaint could be confirmed, since the information for evaluation matches the alleged failure.The device inspection revealed the following: a device inspection was not possible since the affected device was not returned for investigation.An inspection of the images has shown that a broken screw is visible, the screw is broken in two parts at the neck section, that is the weakest point of the whole screw.For further investigation the return of the screw is needed.Further investigation has shown that, in past a nc got initiated, for the same problem, and there were two parts opened and checked for non-conformity, a non-conformance couldn't be confirmed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: MICA SCREW 3.0MM X 36MM FULLY THREADED STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17969624
• Report Number: 3010667733-2023-00614
• Device Sequence Number: 7530796
• Product Code: HWC
• UDI-Device Identifier: 00840420183385
• UDI-Public: 00840420183385
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K162353
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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: 57S13036
• Device Lot Number: 1674849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown