MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 150MM/RT-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.008.010S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is an unknown date in 2019.Complainant part is not expected to be returned for manufacturer review/investigation.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 removal of one (1) hindfoot arthrodesis nail, two (2) 5.0 screws and two (2) 6.0 screws due to the tibia that broke at the proximal screw hole junction.Patient was revised to a new nails and screws.Original date of implant is (b)(6) 2019.Procedure outcome and patient status are unknown.This report is for a 10mm titanium (ti) hindfoot arthrodesis cannulated nail.This is report 1 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.A device history record (dhr) review was conducted: manufacturing location: monument, manufacturing date: 26-aug-2016, expiration date: 31-jul-2025, part number: 04.008.010s, 10mm ti hindfoot arthrodesis cann nail ¿ ex 150mm/rt-sterile, lot number: h151861 (sterile), lot quantity: 5.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 part(s) reviewed: part number: 21012, tialnbri13.00, lot number: 9881635, lot quantity: 1,514 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.The complaint devices were not received for investigation.The following investigation is based on the image/x-ray provided.Visual inspection: a photo/x-ray of the 10mm ti hindfoot arthrodesis cann nail-ex 150mm/rt-sterile (p/n 04.008.010s lot h151861) was received showing no implant failure/defect.No device failure/defect was identified.Conclusion: the complaint condition is not confirmed for the 10mm ti hindfoot arthrodesis cann nail-ex 150mm/rt-sterile (p/n 04.008.010s lot h151861) as the provided x-ray did not show any implant failure/defect.The complaint condition cannot be confirmed with the information available.A definitive root cause could not be determined.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 TI HINDFOOT ARTHRODESIS CANN NAIL-EX 150MM/RT-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: 8712259
• Report Number: 2939274-2019-58745
• Device Sequence Number: 2663463
• Product Code: HSB
• UDI-Device Identifier: 10886982087164
• UDI-Public: (01)10886982087164
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K051678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 05/22/2019

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: 07/31/2025
• Device Model Number: 04.008.010S
• Device Catalogue Number: 04.008.010S
• Device Lot Number: H151861
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 07/02/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR