MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.259S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Implant date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record review was performed for the subject device: item: 04.037.259s, lot: h305207, mfg qty: 6, mfg location: (b)(4), exp date: 31 jan 2027, product was inspected and passed.Product was packaged as required per lppf.Sterilization run report provided by ethicon endo-surgery indicating that product was processed and released with no rejects.Sterile product release checklist indicates all requirements were met and product was released.Planned nonconformance indicated at the qa final inspection operation is not relevant to the complaint condition as this was for removing the need to measure the notch depth using at final inspection as it is measured at mill id.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 the patient was revised to a total hip replacement on (b)(6) 2018, due to pain and breast cancer spreading to the patient leg.The patient was originally implanted with trochanteric fixation nail-advanced (tfna) nail, tfna helical blade and locking screw on an unknown date a year ago.All implants were removed successfully with no issues.It was unknown if there was a surgical delay.Patient outcome was not reported.This is report 1 of 3 for (b)(4).

• Brand Name: 12MM/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: 7677625
• Report Number: 2939274-2018-52805
• Device Sequence Number: 16355930
• Product Code: HSB
• UDI-Device Identifier: 10886982097392
• UDI-Public: (01)10886982097392
• 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): 06/13/2018

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: 04.037.259S
• Device Catalogue Number: 04.037.259S
• Device Lot Number: H305207
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 07/11/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 63