MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 50MM; APPLIANCE,FIXATION,NAIL

Model Number 214.850

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoesthesia (2352)

Event Type  Injury  

Manufacturer Narrative

Additional product code: hwc.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Without a lot number the device history records review could not be completed.Product was not returned.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on or about (b)(6) 2019, the patient underwent an ankle arthroscopy, synovectomy, osteotomy, open reduction internal fixation (orif) of the right fibula because one of the screws had fractured which had caused pain and further injury to her right leg.On (b)(6) 2019, the patient went to the er because of ongoing right foot numbness, loss of sensation post right foot surgery.The patient has been seen by the er physician and was cleared stable to discharge.This report is for 6 of 8 for (b)(4).Related incident: (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Date of implant: (b)(6) 2018.Concomitant medical products: complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 50MM
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9225457
• MDR Text Key: 163755478
• Report Number: 2939274-2019-61715
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982154743
• UDI-Public: (01)10886982154743
• Combination Product (y/n): N
• PMA/PMN Number: K161616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 214.850
• Device Catalogue Number: 214.850
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Weight: 190