MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 360MM/RIGHT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.256S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of the device history records has been requested.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.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 hardware removal on (b)(6) 2018, due to needing a total hip arthroplasty.Patient was initially implanted approximately nine (9) months prior to removal.There was no failure or implant issues.Surgeon had no issues taking out the hardware and the implants performed as expected.There was no surgical delay.The trochanteric fixation nail advanced (tfna) screw, titanium locking screw, and 130 degree titanium cannulated tfna nail were all successfully removed.Patient status is unknown.This report is for one (1) 130 degree tfna nail.This is report 3 of 3 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.Complainant part is not expected to be returned for manufacturer review/investigation.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
Patient outcome was satisfactory.
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.Lot manufacturing location: monument manufacturing date: 09-oct-2017 expiration date: 30-sep-2027 part number: 04.037.256s, 12mm/130 deg ti cann tfna 360mm/right- sterile lot number: h470208 (sterile) lot quantity: 6 work order traveler met all inspection acceptance criteria.Inspection sheet, in-process/inspect dimensional/final, ns063060 rev j met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection, met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev c was reviewed and determined to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.Scn 14201 supplied by ethicon (abq) 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: component parts were not reviewed as the reported complaint condition of ¿removal¿ did not indicate the breakage or failure of any components thus, a dhr review of the components would not be pertinent.Device history batch, device history review - null.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: 12MM/130 DEG TI CANN TFNA 360MM/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: 8032471
• Report Number: 2939274-2018-54743
• Device Sequence Number: 13827547
• Product Code: HSB
• UDI-Device Identifier: 10886982097361
• UDI-Public: (01)10886982097361
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.037.256S
• Device Catalogue Number: 04.037.256S
• Device Lot Number: H470208
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 11/20/2018; 12/06/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 11/27/2018; 12/07/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention