MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 330MM-STERILE; NAIL, FIXATION, BONE

Model Number	04.034.346S
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
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 a patient with a right tibia shaft non-union, four broken titanium locking screws and a possible infection underwent a tibia nail- expert hardware removal was performed on (b)(6) 2018.The surgeon opened the non-union site, retrieved culture samples and removed non-union bone.All screws and broken pieces were removed (distal broken x 4, proximal intact x 2).An expert tibia nail (9mm x 360mm) was removed.A new expert nail was implanted (10mm x 360mm) with three distal screws and two proximal, antibiotic cement was placed at the non-union site.The original implant date is unknown.The revision surgery was successfully completed with no surgical delays.The previously implanted hardware was removed easily.The devices are not available for investigation but photos of the screws were forwarded for investigation.This report is for one (1) 9mm tibial nail-ex.This is report 2 of 3 for complaint (b)(4).

• Brand Name: 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 330MM-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: 7226160
• Report Number: 2939274-2018-50427
• Device Sequence Number: 2378370
• Product Code: JDS
• UDI-Device Identifier: 10886982095107
• UDI-Public: (01)10886982095107(17)EXPIRATIONDATEUNKNOWN(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2018

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: 04.034.346S
• Device Catalogue Number: 04.034.346S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 01/29/2018
• 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