MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/320MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.013.344S
Medical Device Problem Code	No Apparent Adverse Event (3189)
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 on (b)(6) 2019, the patient underwent an open reduction internal fixation (orif) and hardware removal due to implants need to come out for staging and converted to the total hip procedure.The following devices were initially implanted on an unknown date; one (1) retrograde femoral nail, one (1) 5.0mm/60mm titanium locking screw, one (1) 5.0mm/28mm titanium locking screw, unknown dynamic hip and condylar screw system (dhs/dcs) plate, and one (1) dhs/dcs lag screw.Nothing was broken and there was no issue on the devices removed.The procedure was successfully completed without surgical delay.Patient outcome is unknown.This report is for one (1) 9mm ti cann retro/antegrade femoral nail-ex/320mm-sterile.This is report 1 of 5 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.A device history record (dhr) review was conducted: manufacturing location: monument, manufacturing date: 11-dec-2007, expiration date: 01-oct-2016, part number: 04.013.344s, 9mm ti cann retro/antegrade femoral nail-ex/320mm ¿ sterile, lot number: 5656934 (sterile), lot quantity: 6.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(s) reviewed: part number: 21012, tialnbri13.00, lot number: 5215539, lot quantity: 957 lbs.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.

• Brand Name: 9MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/320MM-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: 8644058
• Report Number: 2939274-2019-58313
• Device Sequence Number: 14261905
• Product Code: HSB
• UDI-Device Identifier: 10886982087683
• UDI-Public: (01)10886982087683
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2016
• Device Model Number: 04.013.344S
• Device Catalogue Number: 04.013.344S
• Device Lot Number: 5656934
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 05/27/2019
• Supplement Report FDA Received Date: 06/26/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 81