MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 340MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number 04.037.155S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient identifier: additional patient identifier reported as: (b)(6).Device evaluated by mfr: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.(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 Description

It was reported that the patient underwent revision surgery of the total hip due to avascular necrosis (avn) of femoral head on (b)(6) 2019.The long proximal femoral nailing system (tfna) helical blade was in the patient's pelvis.The device was not broken.There was no surgical delay.Procedure was successfully completed.Patient was revised to a total hip replacement.This report is for one (1) tfna nail.This is report 2 of 3 for complaint (b)(4).

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.The 11 mm/130 degree ti cannulated tfna 340 mm/left ¿ sterile was received with visible signs of implantation and explantation, there are scratches on the device.Surgical intervention for device removal is confirmed.There was no allegation against the product.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.No new malfunctions were observed during the course of this investigation.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 history lot.Manufacturing location: monument, manufacturing date: 08-sep-2016, expiration date: 31-jul-2026, part number: 04.037.155s, 11mm/130 deg ti cann tfna 340mm/left ¿ sterile, lot number: h180586 (sterile).This lot met all dimensional, visual, sterilization 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 ¿helical blade in patient¿s pelvis¿ does not indicate breakage of the nail or any of its components.Therefore, a dhr review of the raw materials would not be pertinent to the reported complaint condition.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: 11MM/130 DEG TI CANN TFNA 340MM/LEFT - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8488178
• MDR Text Key: 141087485
• Report Number: 2939274-2019-57320
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982096630
• UDI-Public: (01)10886982096630
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

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
• Device Operator: Health Professional
• Device Model Number: 04.037.155S
• Device Catalogue Number: 04.037.155S
• Device Lot Number: H180586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 04/24/2019
• Supplement Dates FDA Received: 05/02/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention