MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 5; PRSTHSISKNEEPTELLFMOROTBLSMI-CNSTRINDCMNTDPOLYMRMTALPLYMR

Model Number	74022125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that surgeon had repeated issues with jii femur packaging.The inner package, on several occasions, has been stuck to the outer packaging making it impossible for the nurse to drop the implant into the sterile field.This requires the inner package to be opened off the field and the ¿naked¿ implant passed to the field.This added less than a minute delay.The implants were eventually safely passed to the sterile field and implanted.
Additional Manufacturer Narrative
The device, used in treatment was not returned for evaluation, reporting event could not be confirmed.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.The product support manager for this product line was made aware of the complaint.Possible probable cause could include but not limited to manufacturing process error.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: JRNY BCS II FEMORAL OXIN LT SZ 5
• Common Device Name: PRSTHSISKNEEPTELLFMOROTBLSMI-CNSTRINDCMNTDPOLYMRMTALPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9902884
• Report Number: 1020279-2020-01097
• Device Sequence Number: 11442531
• Product Code: JWH
• UDI-Device Identifier: 00885556170410
• UDI-Public: 00885556170410
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74022125
• Device Catalogue Number: 74022125
• Device Lot Number: 19LM14535
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1