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

Model Number	04.034.449S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Impaired Healing (2378); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight is unknown.Date of mal-union is unknown.Date of implantation is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.(b)(4).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 on (b)(6) 2018, the patient underwent removal of one (1) titanium cannulated tibial nail with proximal bend.Following implantation on an unknown date, the patient had gone back for a follow-up visit and was discovered to have a malunion of the distal tibia.The mal-union was corrected with an osteotomy and another titanium cannulated tibial nail with proximal bend of the same size was implanted.The procedure was successfully completed.It was unknown if there was any surgical delay.The patient outcome is unknown.This report is for a 10mm ti cann tibial nail-ex w/prox bend 345mm-sterile.This is report 1 of 2 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: item: 04.034.449s; lot: h330123; mfg qty: 4; mfg date: march 30, 2017; mfg location: monument; exp date: february 26, 2026; all required inspections were performed and passed per inspection sheets.Sterilization run report received from ethicon endo-surgery indicates the batch was passed and released.Sterile product release checklist indicates that requirements were met and passed.There were no nonconformances (ncs) or reworks generated during the manufacturing of this product.No nonconformance records (ncrs) were generated during production.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 CANN TIBIAL NAIL-EX W/PROX BEND 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: 7613640
• Report Number: 2939274-2018-52540
• Device Sequence Number: 16630880
• Product Code: JDS
• UDI-Device Identifier: 10886982095244
• UDI-Public: (01)10886982095244
• 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,Followup
• Report Date (Section B): 05/24/2018

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: 02/28/2026
• Device Model Number: 04.034.449S
• Device Catalogue Number: 04.034.449S
• Device Lot Number: H330123
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 07/11/2018
• 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: 49 YR