MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 85MM STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.285S
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: part number: 04.038.285ss; lot number: h191504; date of manufacture: 10 february 2017; place of manufacture: (b)(4); part expiration date: 31 january 2027; nonconformance (ncr) noted.Description of dhr review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna helical blade 85mm sterile product was processed through the normal manufacturing and inspection operations but 1 nonconformance was noted.Ncr was written for a cosmetic concern for debris/spots on the part surface found at the anodize operation.The entire (b)(4) piece lot was reworked for a recleaning operation prescribed by the material science sme's and subsequently inspected.The nonconformance is not relevant to the complaint because cosmetic issues alone would not contribute to the need for revision surgery.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.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 2 of 3 for (b)(4).

• Brand Name: TFNA HELICAL BLADE 85MM 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: 7677635
• Report Number: 2939274-2018-52806
• Device Sequence Number: 849108
• Product Code: HSB
• UDI-Device Identifier: 10886982098979
• UDI-Public: (01)10886982098979
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,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: 04.038.285S
• Device Catalogue Number: 04.038.285S
• Device Lot Number: H191504
• 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