MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 20MM; SCREW, FIXATION, BONE

Model Number	204.820
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: jds.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.(b)(4).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 patient was implanted with a variable angle locking compression plate (va lcp) posterolateral distal humerus plate, one (1) 20mm cortex screw, two (2) 18mm cortex screw, one (1) 16mm va locking screw, and two (2) 22mm va locking screws on (b)(6) 2018 for a right distal humerus fracture.During a post-operative visit, surgeon determined there was inadequate fixation for the fracture type.Patient was returned to surgery on (b)(6) 2018 where surgeon removed the implants.It is not known what additional hardware was implanted.Revision surgery was completed successfully.This report is for one (1) 3.5mm cortex screw 20mm.This is report 6 of 7 for (b)(4).
Event or Problem Description
Modified event description update: 11/16/2018 & 11/19/2018: it was reported patient was implanted with a variable angle locking compression (va lcp) posterolateral distal humerus plate, three (3) cortex screws, and three (3) va locking screws on october 11, 2018 for a right distal humerus fracture.During a post-operative visit, surgeon determined that the whole construct fell apart and there was inadequate fixation for the fracture type.Patient was returned to surgery on october 30, 2018 where surgeon removed the implants.It is unknown if there was a surgical delay.Revision surgery was completed successfully.Patient outcome is unknown.
Additional 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.

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 20MM
• 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: 8071652
• Report Number: 2939274-2018-54989
• Device Sequence Number: 19403097
• Product Code: HWC
• UDI-Device Identifier: 10886982146281
• UDI-Public: (01)10886982146281
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2018

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: 204.820
• Device Catalogue Number: 204.820
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/06/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention