MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER; ROD,FIXATION,INTRAMEDULLARY

Model Number 456.355S

Device Problem Device Difficult to Maintain (3134)

Patient Problem No Code Available (3191)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

Additional pro-code: hwc.Exp dae is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history record 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 Description

It was reported that on (b)(6) 2019, during the trochanteric fixation nail (tfn) left hip the locking mechanism would not engage.The locking mechanism in the tfn nail would not lock.The surgeon stated it would not lock and it felt stripped and the surgery was completed with the nail not being locked.There was no surgical delay.Patient status is unknown.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

Event Description

07/03/2019: updated event description: it was reported that on (b)(6) 2019, during the trochanteric fixation nail (tfn) left hip the locking mechanism would not engage.The locking mechanism in the tfn nail would not lock.The surgeon stated it would not lock and it felt stripped and the surgery was completed with the nail not being locked.There was no surgical delay.Patient status is unknown.Concomitant device reported: unknown helical blade (part #: unknown, lot #: unknown, quantity #: 1) unk - nail head elements: tfn helical blade.This complaint involves one (1) device.;.

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.Updated event description provided for reporting.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.A review of the device history record, device history lot manufacturing location: monument, manufacturing date: 03-nov-2012, expiration date: 30-sep-2021, part number: 456.355s, 10mm/130 deg ti cann troch fixation nail 340mm/left- sterile, lot number: 7070973 (sterile), lot quantity:(b)(4).Work order traveler met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev j was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 8855 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 parts reviewed: part number: 456.355s, 10mm/130 deg ti cann troch fixation nail 340mm/left- sterile, lot number: 7059709, lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process acceptance, op033023 rev a met all inspection acceptance criteria.Inspection sheet, inspect dimensional, 456id350 rev u met all inspection acceptance criteria.Inspection sheet, final inspection, 456fi350 rev h met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev h was reviewed and determined to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.Part number: 456.314.3, lock driver tfn, bp55, lot number: 6977188, lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional / final, 456fi314-3 rev h met all inspection acceptance criteria.Part number: 456.315.2, lock 130 bp58, lot number: (b)(4) (qty 5) and (b)(4) (qty 1).Lot quantity: (b)(4) (63 pieces each lot).Work order travelers met all inspection acceptance criteria.Inspection sheets, in-process acceptance sheet, op045442 rev a and rev b met all inspection acceptance criteria.Inspection sheets ns043861 rev d met all inspection acceptance criteria.Part number: 21069, tialnbri18.00, bp80, lot number: 6958146, lot quantity: (b)(4).Product traveler met all inspection acceptance criteria.Certificate of test received from ati allvac dated 21-mar-2012 was reviewed and determined to be conforming.Raw material receiving / putaway checklist met all inspection acceptance criteria.Device history batch null, device history review: 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.

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.H11: corrected data: g4: awareness date reported on follow up 1 report as june 04, 2019 but should have been july 22, 2019.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/130 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8751028
• MDR Text Key: 149759107
• Report Number: 2939274-2019-58960
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982227270
• UDI-Public: (01)10886982227270
• Combination Product (y/n): N
• PMA/PMN Number: K011857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 456.355S
• Device Catalogue Number: 456.355S
• Device Lot Number: 7070973
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2019
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEMENTS: TFN HELICAL BLADE
• Patient Outcome(s): Required Intervention