MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.004.452S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.Date of event is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Therapy date of concomitant device is unknown.A device history record review was requested.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 had a titanium nail implanted in their left fibula on (b)(6) 2015.However, on (b)(6) 2016 the nail broke.Implant was removed on an unknown date.The results of that procedure are currently unknown.Reported concomitant devices: locking screw (part number: 04.005.528, lot number: unknown, quantity: 1), locking screw (part number: 04.005.526, lot number: unknown, quantity: 1), locking screw (part number: 04.005.522, lot number: unknown, quantity: 1).This is report 1 of 1 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: manufacturing location: monument; manufacturing date: 06-jan-2015; expiration date: 11/2023; part #: 04.004.452s, lot #: 7883000 (sterile) - 10mm ti cannulated tibial nail - ex/360mm - sterile; lot quantity: 5; work order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional sheet, in-process acceptance sheet, met all inspection acceptance criteria.Inspection sheet, inspect dimensional sheet, met all inspection acceptance criteria.Inspection sheet, inspection sheet, in-process acceptance 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 # 10890 sterility documentation supplied by ethicon endo-surgery was reviewed and found to be conforming.Part #: 21012 tialnbri13.00 lot #: 7786017; bars were 100% inspected and sorted.Fifteen bars were dispositioned as rts for oversized condition.This ncr would not have contributed to the complaint condition as the raw material od does not affect the final processed dimension (material is removed during the processing).Certificate of report supplied by nf&m dated 13-aug-2014 was reviewed and found to be conforming.Lot summary report for the remainder of the lot dated 22-sep-2014 met all acceptance inspection criteria.Raw material receiving/putaway checklist met all acceptance inspection criteria.No relevant nonconformance records (ncrs) were identified during the dhr review.Investigation summary: the supplied pictures from the flash drive (¿pc-000209622 product pictures 13jun2018¿) was reviewed and the complaint condition of broken postop was confirmed based on images on pages 3-12 (out of 25), it shows the nail has broken from the distal end.As the device was not returned an as received, dimensional, material or drawing reviews are not applicable.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.
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.Patient¿s height reported as 5 feet 10 inches.A5.A: patient¿s ethnicity reported as caucasian 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
Further it was reported that the patient fell while at work on (b)(6) 2018 and fractured his left tibia/fibula.Apparently over the past couple of months the patient had sustained a couple of falls.Post-operatively after the procedure on (b)(6), 2015 to repair his fracture of the left tibia/fibula, the patient was re-admitted to the hospital for pain control.On (b)(6) 2016 the patient twisted his ankle.Reportedly, during january 2016 the patient noticed increasing discomfort over the distal aspect of his tibia.The patient returned for an evaluation on (b)(6) 2016 and a radiograph revealed the fracture of his distal aspect of this intramedullary nail.He was also diagnosed with a non-union and was referred for evaluation.On (b)(6) 2016 the patient underwent a left below the knee amputation with associated removal of hardware which included: synthes locking screws x3, synthes rod x1.The patient tolerated the procedure.Post-operatively patient had a lot of drainage just below the knee whether the nail was removed.The patient received given intravenous iron to treat decrease in hemoglobin and hematocrit.The patient became medically stable and referred for inpatient rehabilitation.

• Brand Name: 10MM TI CANNULATED TIBIAL NAIL-EX/360MM-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: 7665855
• Report Number: 2939274-2018-52728
• Device Sequence Number: 1118529
• Product Code: JDS
• UDI-Device Identifier: 10886982084231
• UDI-Public: (01)10886982084231
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 04.004.452S
• Device Catalogue Number: 04.004.452S
• Device Lot Number: 7883000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 08/02/2018; 08/20/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 08/03/2018; 09/19/2018
• 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: 74 YR
• Patient Weight: 111