MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 105MM; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.305
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary: 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 history lot, device history batch, device history review - null.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 on (b)(6) 2018, the patient underwent a removal of a trochanteric femoral nailing -advanced (tfna) system and had total hip inserted due to cut out.The nail caused pain and stiffness in patients hip.It was unknown if there were any surgical delays.Patient and procedure outcome were unknown.Concomitant device reported: unknown locking screws (part#unknown, lot#unknown, quantity unknown).This complaint involves two (2) devices.This report is for one (1) tfna helical blade 105mm.This report is 2 of 2 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.Patient code 3191 used to capture additional medical/surgical intervention required.Initial reporter is synthes sales representative.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 december 11, 2018, the patient underwent a removal of a trochanteric fixation nail advanced (tfna) system due to helical blade cut out of femoral head.Implanted nail caused pain and stiffness in the patient's hip.The nail and helical blade were removed and patient had total hip inserted.It is unknown if there was surgical delay.Patient and procedure outcome are unknown.Concomitant device: 5.0mm locking screw (part unknown, lot unknown, quantity unknown).

• Brand Name: TFNA HELICAL BLADE 105MM
• 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: 8219345
• Report Number: 2939274-2019-55711
• Device Sequence Number: 264028
• Product Code: HSB
• UDI-Device Identifier: 10886982099044
• UDI-Public: (01)10886982099044
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.038.305
• Device Catalogue Number: 04.038.305
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 01/28/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 118