MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 100MM; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.038.400
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant device is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.(b)(4).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 underwent trochanteric femoral nail advanced (tfna) fenestrated helical blade removal procedure on (b)(6) 2020.The helical blade advanced through the nail and was penetrated into the pelvis.The patient fell at the nursing home and was unable to walk.Procedure outcome and patient status were unknown.Concomitant devices reported: titanium cannulated trochanteric femoral nail advanced sterile (part # 04.005.532, lot # unknown, quantity 1), titanium locking screw with t25 stardrive 42mm femoral intramedullary nail (part # 04.005.532, lot # unknown, quantity 1).This report is for one (1) trochanteric femoral nail advanced (tfna) fenestrated helical blade.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6.Picture review: narrative (blade migration into pelvis) could be confirmed from the provided pictures.Product was not returned as the implants are still implanted.Based on the information available, it has been determined that no corrective and/or preventive 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: a dhr review was not performed for this pi.This is an (b)(4) lot number.Please identify the corresponding monument lot number and resubmit.Part number: 04.038.400-us.Lot number: 12l8016.Part manufacture date: 30-jul-2019.Manufacturing location: (b)(4).Part expiration date: n/a.Non-conformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna fenestrated helical blade 100mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 HELICAL BLADE 100MM
• 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: 10029240
• Report Number: 2939274-2020-02267
• Device Sequence Number: 19679912
• Product Code: HSB
• UDI-Device Identifier: 10886982099280
• UDI-Public: (01)10886982099280
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: 04.038.400
• Device Catalogue Number: 04.038.400
• Device Lot Number: 12L8016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 05/25/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11MM/125 DEG TI CANN TFNA 170MM - STERILE.; 5.0MM TI LOCKING SCREW.; 11MM/125 DEG TI CANN TFNA 170MM - STERILE; 5.0MM TI LOCKING SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 80