MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.159S
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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of postoperative femur breakage is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Patient code (b)(4) used to capture additional medical/surgical intervention required.A device history record (dhr) review was conducted for part: 04.037.159s, lot: h277015: mfg qty: 6, mfg date: 26 jan 2017, scn: (b)(4), exp date: 31 dec 2026: product was inspected and passed.Product was packaged per lppf.There were no non-conformances (ncs) or reworks generated during the manufacturing of this lot.Sterilization run report received from ethicon endo-surgery and indicates product passed per requirements.Sterile product release checklist indicates requirements were met and product released.No non-conformance reports (ncrs) 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.Product was not returned.Based on the information available, it has been determined that no corrective and 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 or Problem Description
It was reported that on (b)(6) 2018, patient underwent removal of titanium cannulated fixation nail-advanced (tfna), tfna fenestrated screw and two (2) titanium locking screws due to patient broke the femur bone again.Devices were originally implanted on an unknown date.There were no allegations against the devices yet the surgeon decided to convert the implants to a total hip replacement.All implants were removed easily and intact with no surgical delay.Patient outcome was stable.This report is for one (1) 11mm/130 degree ti cannulated tfna 380mm/left - sterile.This is report 1 of 3 for complaint (b)(4).

• Brand Name: 11MM/130 DEG TI CANN TFNA 380MM/LEFT - 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: 7639353
• Report Number: 2939274-2018-52638
• Device Sequence Number: 11145328
• Product Code: HSB
• UDI-Device Identifier: 10886982096678
• UDI-Public: (01)10886982096678
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

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
• Operator of Device: Health Professional
• Device Model Number: 04.037.159S
• Device Catalogue Number: 04.037.159S
• Device Lot Number: H277015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 06/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR