MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.034.555S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient height reported as 5¿11¿ (b)(6).Date infection and non-union began is not known complainant part is not expected to be returned for manufacturer review/investigation.Dhr review was completed.Item: 04.034.555s lot: h213274 mfg qty: 6 mfg location: (b)(4) mfg date: 21 oct 2016 exp date: 30 sep 2025 scn: (b)(4).There were no ncs or reworks identified in the dhr.Product was inspected to and passed all requirements.Dhr indicates product was packaged per requirements.Scn file indicates product was sterilized at ethicon endo-surgery using the gamma 25-40kgy method.Sterilization run report was provided by ethicon endo-surgery indicating that product was passed with all dosimeters in range.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 patient was implanted with the 11mm cannulated tibial nail-ex and six (6) 5.0mm locking screws on (b)(6) 2017.On unknown date, patient presented with a flashed open tibial-fibular fracture from a motor vehicle accident, as well as an infection and non-union.Patient was returned to surgery on (b)(6) 2018 where all hardware was removed.Surgery was completed successfully with no delay.Patient outcome is unknown.This report is for one (1) 11mm cannulated tibial nail-ex this is report 1 of 2 for (b)(4).

• Brand Name: 11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-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: 7571636
• Report Number: 2939274-2018-52416
• Device Sequence Number: 11092243
• Product Code: JDS
• UDI-Device Identifier: 10886982095398
• UDI-Public: (01)10886982095398
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2018

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 Expiration Date: 09/30/2025
• Device Model Number: 04.034.555S
• Device Catalogue Number: 04.034.555S
• Device Lot Number: H213274
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 06/05/2018
• 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 Age: 28 YR
• Patient Weight: 71