MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE; NAIL, FIXATION, BONE

Model Number	04.004.243S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id/initials, age/date of birth and weight are unknown.Unknown date in 2017.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 that the patient is scheduled to undergo revision on (b)(6) 2018, to remove the following hardware: one (1) titanium cannulated tibial nail, one (1) locking compression plate (lcp) plate 6 holes, one (1) titanium locking screw 60mm, one (1) titanium locking screw 76mm, one (1) titanium locking screw 30mm, one (1) titanium locking screw 50mm and one (1) cortex screw self-tapping, due to osteomyelitis.The hardware was originally implanted for a fracture repair surgery to the right tibia on an unknown date in 2017.This is report 1 of 7 for (b)(4).
Event or Problem Description
The removal surgery scheduled for on (b)(6) 2018 has been canceled.Removal surgery will take place, but the rescheduled date is as yet unknown.
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.Additional narrative: event: updated.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: 8MM TI CANNULATED TIBIAL NAIL-EX/315MM-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: 7758130
• Report Number: 2939274-2018-53220
• Device Sequence Number: 19258757
• Product Code: JDS
• UDI-Device Identifier: 10886982083616
• UDI-Public: (01)10886982083616
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2018

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: 04.004.243S
• Device Catalogue Number: 04.004.243S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 09/13/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention