MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE; NAIL, FIXATION, BONE

Model Number	04.004.549S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.(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) 2020, the patient underwent removal of the expert tibial nail, five (5) 5.0mm locking screws and two (2) 4.0mm cannulated screws.The reason for the removal of the implants was due to non-union and the patient anatomy fell into valgus from implant failure.During the revision procedure, all the original implants were removed and the patient was revised to a new tibial nail and fibula locking plate.The procedure was successfully completed without a surgical delay.Patient status is unknown.This report is for one (1) 11mm ti cannulated tibial nail-ex/ 345mm-sterile.This is report 1 of 8 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 history: part number: 04.004.549s, 11mm ti cannulated tibial nail - ex/345mm - sterile.Lot number: 6456599 (sterile).Manufacturing location: (b)(4).Manufacturing date: 19-aug-2010.Expiration date: 31-jul-2019.Lot quantity: 6.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process acceptance sheet, met all inspection acceptance criteria.Inspection sheet, inspect dimensional, met all inspection acceptance criteria.Inspection sheet, final inspection, met all inspection acceptance criteria.Packaging label log, was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 7039 supplied by sterigenics 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.Component part(s) reviewed: part number: 21012, tialnbri13.00.Lot number: 6278837.Lot quantity: 2,902 lbs.Product traveler met all inspection acceptance criteria.Certified test report supplied by perryman company dated 10-apr-2009 and inspection certificate supplied to perryman by vsmpo dated 30-sep-2006 were reviewed and determined to be conforming.Raw material receiving/putaway checklist met all inspection acceptance criteria.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.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: 11MM 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: 10239605
• Report Number: 2939274-2020-03121
• Device Sequence Number: 2496322
• Product Code: JDS
• UDI-Device Identifier: 10886982084491
• UDI-Public: 10886982084491
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2020

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: 07/31/2019
• Device Model Number: 04.004.549S
• Device Catalogue Number: 04.004.549S
• Device Lot Number: 6456599
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 08/04/2020; 08/05/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 08/05/2020; 08/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention