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 Codes	Unspecified Infection (1930); Impaired Healing (2378); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient ethnicity is unknown.Date of infection and non-union is unknown.Date of implantation is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4); manufacturing date: november 26, 2014; expiration date: october 2023; part: 04.004.549s, lot: 7860917 (sterile) - 11mm ti cannulated tibial nail - ex/345mm ¿ sterile; lot quantity: 6.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process acceptance sheet, met all inspection acceptance criteria.Inspection sheet, inspect dimensional, met all inspection acceptance criteria.Inspection sheet, final inspection, met all inspection acceptance criteria.Packaging label log, was reviewed and was found to be conforming: packaging 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 nonconformance reports (ncrs) 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.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 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 on (b)(6) 2018, the patient underwent hardware removal of a titanium (ti) cannulated tibial nail-expert with two (2) locking screws, and a locking compression plate (lcp) lateral distal fibula plate with two (2) locking screws and four (4) cortex screws due to an infection of non-union.Inflammation with pus was noted in the medullary canal.The implantation date of the hardware is unknown.The procedure was completed successfully with no surgical delay.Patient outcome is unknown.This report is for a 11mm ti cannulated tibial nail-ex/345mm-sterile.This is report 2 of 4 for (b)(4).
Event or Problem Description
This is report 2 of 5 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 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: 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: 7735046
• Report Number: 2939274-2018-53132
• Device Sequence Number: 805481
• Product Code: JDS
• UDI-Device Identifier: 10886982084491
• UDI-Public: (01)10886982084491
• 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 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): 07/16/2018

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: 10/31/2023
• Device Model Number: 04.004.549S
• Device Catalogue Number: 04.004.549S
• Device Lot Number: 7860917
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 08/10/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 77