MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 105MM - STERILE; APPLIANCE,FIXATION,NAIL

Model Number	04.038.405S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event year is reported as 2020; however exact date of event is unknown.Reporter is jnj representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 an unknown date, patient underwent removal of proximal femoral nailing system (tfna) nail that was broken after six (6) months of implantation.Originally implanted with tfna nail, tfna blade and unknown locking screws on an unknown date.The fenestrated helical blade was intact, there was indentations on the blade due to the nail breaking around it.Fragments were completely removed.Removal was done fairly easily without significant intervention, then a total hip arthroplasty was completed.There was patient consequence reported.Concomitant device reported: unknown locking screw (part# unknown, lot# unknown, quantity 1).This complaint involves two (2) devices.This report is for (1) 11mm/125 deg ti cann tfna 360mm/right - sterile.This is report 2 of 2 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.H10 additional narrative: h3, h4, h6- the tfna fenestrated helical blade 105mm - sterile (p/n: 04.038.405, lot number: h486971) was received at us cq.Visual inspection of the complaint device showed some cosmetic nicks and scratches, but no other damage.This complaint is not confirmed as no non-cosmetic damage is observed.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot device history review done by gabrielle truong on 21 july 2020.Part number: 04.038.405s lot number: h486971 part manufacture date: 27 november 2017 manufacturing location: elmira part expiration date: 31 october 2027 nonconformance noted: n/a a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna fenestrated helical blade 105mm was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.The 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.A review of the device history record for the raw material revealed no complaint related anomalies.The device history record shows this lot met all requirements at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.The 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.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: TFNA FENESTRATED HELICAL BLADE 105MM - STERILE
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10311324
• Report Number: 2939274-2020-03277
• Device Sequence Number: 14031046
• Product Code: KTT
• UDI-Device Identifier: 10886982099310
• UDI-Public: (01)10886982099310
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.038.405S
• Device Catalogue Number: 04.038.405S
• Device Lot Number: H486971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 08/20/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention