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 Code	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.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.Based on the information available, it has been determined that no corrective and/or 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 that on (b)(6) 2018, the patient underwent a tibial nail removal due to nonunion.It is unknown if there was any surgical delay.Patient outcome was stable.The procedure was successfully completed, and the fracture was plated with a large fragment plate.This report is for one (1) 10mm ti cannulated tibial nail.This is report 1 of 3 for complaint (b)(4).
Additional Manufacturer Narrative
A review of the device history record.Lot manufacturing location: (b)(4).Manufacturing date: 29-sep-2017.Expiration date: 31-aug-2026.Part number: 04.004.449s, 10mm ti cannulated tibial nail - ex/345mm ¿ sterile.Lot number: h461484 (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 met all inspection acceptance criteria.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.Sterility documentation supplied by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture 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.

• 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: 8038463
• Report Number: 2939274-2018-54789
• Device Sequence Number: 13827746
• Product Code: JDS
• UDI-Device Identifier: 10886982084217
• UDI-Public: (01)10886982084217
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 10/18/2018

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: 08/31/2026
• Device Model Number: 04.004.449S
• Device Catalogue Number: 04.004.449S
• Device Lot Number: H461484
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 12/07/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention