MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 240MM/LT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.008.078S

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

Patient Problems Unspecified Infection (1930); Inflammation (1932); No Code Available (3191)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.Device history lot: manufacturing location: (b)(4), manufacturing date: 12-mar-2014, part number: 04.008.078, 10mm ti hindfoot arthrodesis cann nail ¿ ex 240mm/ left, lot number: 7630108 (non-sterile), lot quantity: (b)(4).Note: this lot number was produced as a non-sterile item.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process acceptance sheet, op038354 rev a met all inspection acceptance criteria.Inspection sheet, ns037189 rev c met all inspection acceptance criteria.Inspection sheet, final inspection, 04fi008010 rev d met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev ab was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device history review: 14-nov-2019: dhr reviewed by: (b)(4).This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 on (b)(6) 2019, the patient underwent a revision surgery due to chronic osteomyelitis, infection, inflammation, nonunion of joint, and delayed healing.One (1) hindfoot nail, one (1) spiral blade, one (1) 6mm unknown locking screw, and one (1) 5mm unknown locking screw were removed.All hardware was intact.After the removal, the extremity of the patient was i&d using ria.There was no surgical delay.  it is unknown if procedure was successfully completed.Patient status was good.This complaint involves four (4) devices.This is 1 of 4 for report (b)(4).

• Brand Name: 10MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 240MM/LT-STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9342513
• MDR Text Key: 185044394
• Report Number: 2939274-2019-62275
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982087218
• UDI-Public: (01)10886982087218
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.008.078S
• Device Catalogue Number: 04.008.078S
• Device Lot Number: 7630108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 93