MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/125 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.401S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter is synthes sales representative.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) 2019, patient underwent total hip surgery wherein trochanteric fixation nail (tfn) and titanium helical blade was explanted.Operative notes say that 125 degree nail was put in the patient but the doctor did not have a 125 degree helical blade aiming arm so tried to use 130 degree arm.The helical blade was left upside down in the patient and nail.Due to this, the nail could not be locked.Surgical delay was unknown.Patient outcome status is unknown.Concomitant device/s reported: unknown locking screw (part # unknown, lot # unknown, quantity of 1).This report is for one (1) 11mm/125 deg ti cann troch fixation nail 400mm/left-ster.This is report 2 of 2 for (b)(4).
Event or Problem Description
It is unknown if the device failed.It was used improperly and could not be locked because the helical blade was upside down.Therefore, this construct could not have worked as it was designed to.
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.Part number: 456.401s, 11mm/125 deg ti cann troch fixation nail 400mm/left- sterile, lot number: 5360689 (sterile), lot quantity: 6, manufacturing location: monument, manufacturing date: 31-oct-2007, expiration date: 01-sep-2016.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process acceptance, 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 4797 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: 456.314.2, lock 125, bp55, lot number: 5536512, lot quantity: 210.Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming inspection, met all inspection acceptance criteria.Certificate of compliance supplied by mark two engineering dated 13-jul-2007 was reviewed and determined to be conforming.456.314.3, lock driver tfn, bp55, lot number: 5536586, lot quantity: 210.Work order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional / final, met all inspection acceptance criteria.Part number: 21069, lot number: 5172172, lot quantity: 3,678 lbs.Product traveler met all inspection acceptance criteria.Inspection sheet, raw material inspection, met all inspection acceptance criteria.Certificate of test supplied by allvac dated 07-jun-2007 was reviewed and determined to be conforming.Raw material receiving / putaway checklist met all inspection acceptance criteria.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.H3, h4, h6: a review of the updated (dhr) device history record to include sterile: manufacturing location: monument.Manufacturing date: 31-oct-2007.Expiration date: 01-sep-2016.Part number: 456.401s, 11mm/125 deg ti cann troch fixation nail 400mm/left- sterile.Lot number: 5630689 (sterile).Lot quantity: 6.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process acceptance, 456ipa391 rev c met all inspection acceptance criteria.Inspection sheet, inspect dimensional, 456id390 rev r met all inspection acceptance criteria.Inspection sheet, final inspection, 456fi390 rev f met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev g was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 4797 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: 456.314.2, lock 125, bp55.Lot number: 5536512.Lot quantity: 210.Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming inspection, 456fi314 rev k met all inspection acceptance criteria.Certificate of compliance supplied by mark two engineering dated 13-jul-2007 was reviewed and determined to be conforming.456.314.3, lock driver tfn, bp55.Lot number: 5536586.Lot quantity: 210.Work order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional / final, 456fi314-3 rev e met all inspection acceptance criteria.Part number: 21069, tialnbri18.00, bp80.Lot number: 5172172.Lot quantity: 3,678 lbs.Product traveler met all inspection acceptance criteria.Inspection sheet, raw material inspection, rmtialnbr118_00 rev h met all inspection acceptance criteria.Certificate of test supplied by allvac dated 07-jun-2007 was reviewed and determined to be conforming.Raw material receiving / putaway checklist met all inspection acceptance criteria.Device history batch null, device history review 02-jul-2019: dhr, 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.H3, h6: investigation summary.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 11MM/125 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8744238
• Report Number: 2939274-2019-58913
• Device Sequence Number: 16785671
• Product Code: HSB
• UDI-Device Identifier: 10886982227690
• UDI-Public: (01)10886982227690
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/23/2019

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: 09/01/2016
• Device Model Number: 456.401S
• Device Catalogue Number: 456.401S
• Device Lot Number: 5630689
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/28/2019; 07/23/2019; 07/31/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 07/01/2019; 07/26/2019; 08/01/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW
• Outcome Attributed to Adverse Event: Required Intervention