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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); No Code Available (3191)
Date of Event	11/05/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9342513
• Report Number: 2939274-2019-62275
• Device Sequence Number: 16847060
• Product Code: HSB
• UDI-Device Identifier: 10886982087218
• UDI-Public: (01)10886982087218
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K051678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 04.008.078S
• Device Catalogue Number: 04.008.078S
• Device Lot Number: 7630108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 11/19/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 93