MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 30MM; PLATE,FIXATION,BONE

Model Number	02.211.030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Impaired Healing (2378)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code hwc.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 a patient underwent a revision surgery on (b)(6) 2018, due to a nonunion and hardware failure.Patient initially had an open reduction and internal fixation surgery on (b)(6) 2018, to treat a left distal humerus fracture.The implanted devices were variable angle distal humerus plate, variable angle-lcp lat distal humerus plate, eight (8) variable angle locking screw self-tping with t8 stardrive, variable angle locking screw self-tping with t8 stardrive, variable angle-lcp proximal olecranon, and four (4) ortex screw self- tapping.The procedure was completed, and all hardware was removed intact.The fracture was reduced, and an unknown variable angle elbow plate with unknown screws were used for fixation.The procedure was completed successfully, and the patient was stable.This report is for one (1) 2.7mm va lckng screw slf-tpng with t8 stardrive recess 30mm this is report 4 of 10 for (b)(4).Due to a limit of impacted products per complaint, this complaint is a continuation from complaint (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.Corrected data: it was reported not all the devices were removed during the explant procedure, but it is unknown which devices were explanted and which remained in the patient.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.
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.Exact date of event is unknown, reportedly the event occurred sometime in 2018.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: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 30MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8129082
• Report Number: 2939274-2018-55244
• Device Sequence Number: 1486986
• Product Code: HRS
• UDI-Device Identifier: 10886982053664
• UDI-Public: (01)10886982053664
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2018

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: 02.211.030
• Device Catalogue Number: 02.211.030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 01/03/2019; 01/03/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/03/2019; 01/04/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR