MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE; NAIL, FIXATION, BONE

Model Number	04.004.549S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Infection (4544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation, part was discarded by the facility.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.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: a dhr review could not be performed for this pi.Lot number 56p6792 belongs to p/n 04.037.260s.Device history batch null, device history review 21-jan-2021, a dhr review could not be performed for this pi.Lot number 56p6792 belongs to p/n 04.037.260s.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) 2021, patient will undergo a hardware removal.A tibial nail was to be removed and the nail was removed because of a possible infection.The nail was inserted as a part of a removal of a stryker tibial nail, bone grafting, and insertion of synthes tibial nail in (b)(6) of 2020.The patient had recurrent skin infections and ultimately lead to the removal of the nail as a precaution.According to the surgeon the nonunion from (b)(6) seems to be healing, there was no surgical delay reported.Concomitant products: 11mm ti cannulated tibial nail-ex/345mm-sterile, lot (2l94168), part (304.004.549s-us) quality unknown; unk - screws: locking, lot & part number unknown, qty (2).This complaint involves three (3) devices.This report is for one (1) 11mm ti cannulated tibial nail-ex/345mm-sterile.This report is 1 of 3 for (b)(4).

• Brand Name: 11MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11273750
• Report Number: 2939274-2021-00641
• Device Sequence Number: 11636380
• Product Code: JDS
• UDI-Device Identifier: 10886982084491
• UDI-Public: (01)10886982084491
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2021

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: 04.004.549S
• Device Catalogue Number: 04.004.549S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/03/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Weight: 77