MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/315MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.016.315S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Date of implant is unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review is pending completion.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 an unknown date, in an attempt to do an ankle arthrodesis, a multiloc humeral nail and locking screws were implanted to mimic an arthrodesis nail on a left distal tibia (an off-label use as described by the sales consultant) in (b)(6) on (b)(6) 2017, a hardware removal and revision was performed to change the treatment option in an attempt to salvage a limb.The surgeon in (b)(6)(surgeon for revision surgery) was of the opinion that the patient's affected limb should be amputated, however, the patient decided that she wanted to keep the limb.Hence, the surgeon decided on another treatment option in an attempt to salvage the limb by revising the patient to another set of hardware.The surgeon proceeded with removing the initially implanted hardware which included one (1) intact multiloc humeral nail, two intact (2) 4.0 mm locking screws and two intact (2) 4.5 mm locking screws, which were removed uneventfully.There was no reported surgical delay, additional medical interventions or additional x-rays required.The patient was revised to a competitor¿s ilizarov frame, which is an external fixation device.The procedure was completed successfully with the patient in stable condition.This report is for one (1) 7 mm ti multiloc humeral nail right/cann/315 mm-sterile.This is report 2 of 3 for (b)(4).

• Brand Name: 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/315MM-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: 7110256
• Report Number: 2939274-2017-50232
• Device Sequence Number: 85681
• Product Code: HSB
• UDI-Device Identifier: 10886982089311
• UDI-Public: (01)10886982089311(17)EXPIRATIONUNKNOWN(10)97119701
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2017

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: 04.016.315S
• Device Catalogue Number: 04.016.315S
• Device Lot Number: 97119701
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 57