MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/125 DEG TI CANN TFNA 440MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.234S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 the patient underwent a revision hip surgery on an unknown date.A trochanteric fixation nail advanced (tfna) nail cut out through the top.Hardware removal of all implants, including a helical blade and two (2) distal locking screws located at the most distal hole of the nail and the dynamic hole.The nail was implanted in (b)(6) 2018.The surgeon replaced the device with a biomet cemented hemi hip.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.Concomitant devices reported: unknown locking screws (part# unknown, lot# unknown, quantity 2).Helical blade (part# 04.038.300, lot # unknown, quantity 1).This report is for one (1) 12mm/125 deg ti cann tfna 440mm/right - sterile.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.H10 additional narrative: h3, h6: manufacturing location: monument; manufacturing date: march 16, 2016; expiration date: february 28, 2026; part: 04.037.234s; 12mm/125 deg ti cann tfna 440mm/right- sterile; lot: h055913 (sterile); lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria one piece was scrapped in cell at mill distal holes for dimension ¿l2¿ being out of specification.Inspection sheet, in-process/inspect dimensional/final met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label log lppf was reviewed and determined to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.Sterilization control number (scn) 12307 supplied by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual 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: component parts were not reviewed because the reported complaint condition of ¿cut out through the top' was not related to breakage of any component of the nail, therefore, device history record (dhr) review of the raw material(s) would not be relevant to the reported 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 12MM/125 DEG TI CANN TFNA 440MM/RIGHT - STERILE
• 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: 8180457
• Report Number: 2939274-2018-55476
• Device Sequence Number: 11339651
• Product Code: HSB
• UDI-Device Identifier: 10886982097200
• UDI-Public: (01)10886982097200
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 11/28/2018

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: 02/28/2026
• Device Model Number: 04.037.234S
• Device Catalogue Number: 04.037.234S
• Device Lot Number: H055913
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 01/17/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE EVENT DESCRIPTION.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Weight: 106