MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 170MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number 04.037.142S

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

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Type  Injury  

Manufacturer Narrative

This information is unknown.Event date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter email is unknown.Manufacturing location: monument.Manufacturing date: 31-may-2017.Expiration date: 30-apr-2027.Part #: 04.037.142s, lot#: h375116 (sterile) - 11mm/130 deg ti cann tfna 170mm - sterile.Quantity 5.Inspection sheet for in-process/inspect dimensional/final and tfna assembly met.Inspection acceptance criteria.Component parts reviewed: the 04.037.914.2 - lock prong 130 degree, tfna bp-55 lot ¿ l367739 (1), l367715 (4).The 04.037.912.4 - wave spring, shim ended bp-55 lot - h249502.The 04.037.912.3 - tfna lock drive bp-58 lot ¿ h363662.The 21127 - raw material lot bp-80 lot - h126763.Raw material for ti was received from perryman company.Certified test report received from (b)(6) and certificate of test for titanium ingot received from alcoa meet specification.Raw material receiving/putaway checklist meet requirements.No non conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.Product was not returned.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 Description

It was reported that a hardware removal and revision was performed on (b)(6) 2018.The patient was initially treated for an intertrochanteric fracture on (b)(6) 2017 when the patient was implanted with one (1) 11 mm/130-degree tfna short nail, tfna 100 mm helical blade and a 5.00 mm locking screw.The removal surgery was performed due to the patient¿s poor bone quality.Surgeon removed the short tfna nail and revised it to a total hip.The surgeon also removed the locking screw and the 100mm blade.The removal surgery went without any complications.Patient status is unknown.This complaint is for a 11mm/130 deg ti cann tfna 170mm - sterile.This is report 1 of 3 for (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.This mfr received date was incorrectly reported as 4/25/2018.The correct date is 4/17/2018.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 170MM - 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: 7496356
• MDR Text Key: 107660131
• Report Number: 2939274-2018-52078
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982096548
• UDI-Public: (01)10886982096548
• 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: 04/17/2018

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
• Device Operator: Health Professional
• Device Model Number: 04.037.142S
• Device Catalogue Number: 04.037.142S
• Device Lot Number: H375116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/08/2018
• Supplement Dates Manufacturer Received: 05/09/2018
• Supplement Dates FDA Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR