MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; SCREW,FIXATION,BONE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for three (3) unknown 3.5 cortex screws /unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer.Without a lot number the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient¿s ankle surgery was revised because she was non-compliant and walked on it too early causing the screws to loose purchase in the bone.This led to instability of the ankle and reoperation.Three unknown 3.5 cortex screws were removed intact and were not broken and 4 cortex screws were added for syndesmosis fixation.Revision procedure was successful and patient outcome is reported as stable.Original surgery was (b)(6) 2018.This report is for three (3) unknown 3.5 cortex screws.This is report 1 of 1 for (b)(4).

• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7596567
• MDR Text Key: 110909877
• Report Number: 2939274-2018-52487
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR