MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 115MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.038.215S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).Event year reported as 2019, exact date of postoperative screw migration is unknown.Additional device product code: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.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 or Problem Description
It was reported that on (b)(6) 2019, patient underwent removal due to catastrophic failure with protrusion of lag screw into pelvis.The trochanteric fixation nail advance (tfna) fenestrated screw migrated through the titanium cannulated (tfna) nail and into the pelvis.Patient fell and rammed the titanium cannulated (tfna) nail.Hospital has maintained control of the implant.Tfna implants were removed and were replaced by a total hip arthroplasty (tha).There was no surgical delay.Procedure was successfully completed.Patient outcome was good.Initial implant date is (b)(6) 2019.Concomitant devices reported: unknown trochanteric fixation nail advance (tfna) nail (part #: 04.037.042s, lot #: h761295, quantity # 1).This report is for one (1) tfna fenestrated screw.This is report 1 of 1 for complaint (b)(4).
Event or Problem Description
Concomitant devices reported: unknown trochanteric fixation nail advance (tfna) nail (part #: 04.037.042s, lot #: h761295, quantity # 1), unknown helical blade (part #: unknown, lot #: unknown, quantity # 1).
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.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: TFNA FENESTRATED SCREW 115MM - 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: 8613550
• Report Number: 2939274-2019-58050
• Device Sequence Number: 2115093
• Product Code: HSB
• UDI-Device Identifier: 10886982098832
• UDI-Public: (01)10886982098832
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.038.215S
• Device Catalogue Number: 04.038.215S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 06/14/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10MM/130 DEG TI CANN TFNA 170MM - STERILE; 10MM/130 DEG TI CANN TFNA 170MM - STERILE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR