MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.004.449S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Skin Erosion (2075)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.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 a 10mm cannulated tibial nail, 5.0mm locking screw, 3.5mm locking compression plate (lcp) fibula plate, and six (6) unknown 3.5mm cortex screws on (b)(6) 2018.On unknown date patient developed skin breakdown and infection at the implant site.Patient was returned to surgery on (b)(6) 2018 where all hardware was removed.An antibiotic rod was placed until patient infection is cleared.Surgery was completed successfully with no delay.Patient status reported as stable.This report is for one (1) 10mm cannulated tibial nail.This is report 1 of 4 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device history record (dhr) review: manufacturing location: monument; manufacturing date: february 26, 2018; expiration date: january 31, 2027; part #: 04.004.449s, lot #: h574404 (sterile) - 10mm ti cannulated tibial nail - ex/345mm - sterile; lot quantity:(b)(4).Work order traveler met all inspection acceptance criteria.In-process acceptance inspection sheet, met all inspection acceptance criteria.Inspect dimensional inspection sheet met all inspection acceptance criteria.Final inspection sheet met all inspection acceptance criteria.Packaging label log was reviewed and was found to be conforming: packaging bill of materials (bom) for this lot was reviewed and found to be conforming with no deviations to normal packaging identified.Scn # (b)(4) sterility documentation supplied by ethicon endo-surgery was reviewed and found to be conforming.No nonconformances (nrs) were generated during the production of this lot.Review of the device history record(s) showed that there were no issues during the manufacture of the product 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.

• Brand Name: 10MM 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: 7687529
• Report Number: 2939274-2018-52876
• Device Sequence Number: 756859
• Product Code: JDS
• UDI-Device Identifier: 10886982084217
• UDI-Public: (01)10886982084217
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018

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 Model Number: 04.004.449S
• Device Catalogue Number: 04.004.449S
• Device Lot Number: H574404
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 08/17/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR