MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/12MM; SCREW, FIXATION, BONE

Model Number	206.016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.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) 2018, the patient underwent a right total knee arthroplasty revision to address loosening of the tibia at the cement to implant interface.It was noted the original implant date was (b)(6) 2016.During the procedure, it was identified that two (2) synthes screws were used along the lateral side to act as rebarb for cement, upon releasing the tourniquet, a large rush of blood was observed from the posterior knee.The bleeding was controlled and the patient was in stable condition with no apparent complications.This is report 1 of 2 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.The initial complaint was reviewed and found not reportable.This (b)(4) has no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of a synthes device after it is released for distribution.There is no report of an adverse event involving a synthes device.Per crb review: crb review 2-jan-2019 this will be not reportable, the screws were not related to the bleeding.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: 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/12MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9538503
• Report Number: 2939274-2020-00007
• Device Sequence Number: 2407766
• Product Code: HWC
• UDI-Device Identifier: 10886982147233
• UDI-Public: (01)10886982147233
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K083213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 206.016
• Device Catalogue Number: 206.012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/02/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR