MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 90MM STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.038.290S

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of device cut out reported as 2018, exact date is not known complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history records has been requested.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.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 Description

It was reported that on (b)(6) 2018 during on an unknown procedure, the trochanteric fixation nail advanced (tfna) long nail one (1), titanium helical blade one (1),and unk - screws: locking: trauma one (1), all the hardware was removed due to the left hip pain and the implant had cut out of the femoral head and replaced with hemiarthroplasty.The initial implant was on (b)(6) 2018.There were no known comorbidities.There was no patient consequence reported.It is unknown if there was surgical delay.Procedure and patient outcome is unknown.This complaint involves three (3) devices.

Manufacturer Narrative

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.

Manufacturer Narrative

Additional information provided.Complainant part is not expected to be returned for manufacturer review/investigation.Part: 04.038.290s; lot: h300531; date of manufacture: march 23, 2017; place of manufacture: elmira; part expiration date: february 28, 2027; nonconformance noted: n/a.A review of the device history record (dhr) revealed no complaint related anomalies.The device history record shows this lot of tfna helical blade 90mm sterile 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.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 Description

It was reported that on (b)(6) 2018, a trochanteric fixation nail advanced (tfna) was removed due to cut out of the helical blade through the superior aspect of the femoral head and replaced with hemiarthroplasty.The tfna was originally implanted on (b)(6) 2018.During an appointment, the patient complained of left hip pain and it was noted on the x-rays that the implant had cut out of the femoral head.The procedure successfully completed with no surgical delay reported.Patient outcome is unknown.Concomitant devices: tfna nail (part: 04.037.142s, lot: h496404, quantity: 1), locking screw (part: unknown, lot: unknown, quantity: 1) this report is for a tfna helical blade 90mm sterile.This is report 1 of 1 for (b)(4).

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.Visual inspection: visual inspection of the returned device performed at customer quality identified surface wear consistent with implantation and explantation but no damage or abnormalities that would contribute to the reported complaint condition was observed.No x-rays or visual evidence of the device cut-out were provided.Dhr review: the returned device was manufactured in march 2017.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna helical blade 90mm sterile 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.Document/specification review: no product design issues or discrepancies were observed during this investigation.Dimensional inspection: the outside diameter of the distal helical tip measured 10.29mm which is within specification conclusion: a definitive root cause for the reported condition of cut-out could not be determined based on the provided information.This complaint was not able to be confirmed and no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation and this complaint condition is adequately covered by the risk assessment.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part number: 04.038.290s.Lot number: h300531, date of manufacture: 23 march 2017, place of manufacture: elmira, part expiration date: 28 february 2027, nonconformance noted: n/a.Review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna helical blade 90mm sterile 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 HELICAL BLADE 90MM STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8088632
• MDR Text Key: 127855180
• Report Number: 2939274-2018-55036
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982098993
• UDI-Public: (01)10886982098993
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.038.290S
• Device Catalogue Number: 04.038.290S
• Device Lot Number: H300531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Date Manufacturer Received: 02/13/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR