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	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 that on (b)(6) 2019, the patient underwent a hardware removal due to pain.One (1) variable angle locking compression plate posterolateral distal humerus plates with lateral support, one (1) variable angle locking compression plate extended medial distal humerus plates, one (1) cortex screw self-tapping 50mm, one (1) cortex screw self-tapping 20mm, one (1) cortex screw self-tapping 24mm, three (3) cortex screws self-tapping 20mm, one (1) cortex screw self-tapping 22mm, one (1) cortex screw self-tapping 26mm, one (1) variable angle locking screw self-tapping with t8 stardrive recess 14mm, one variable angle locking screw self-tapping with t8 stardrive recess 16mm, one (1) variable angle locking screw self-tapping with t8 stardrive recess 22mm, one (1) variable angle locking screw self-tapping with t8 stardrive recess 30mm, one (1) variable angle locking screw self-tapping with t8 stardrive recess 40mm and one (1) variable angle locking screw self-tapping with t8 stardrive recess 50mm.Some screws were broken and left.Other screws were left in the body.It is unknown if what screws were left/broken.There was no surgical delay.Procedure was successfully completed.Patient status was unknown.This report is for one (1) 3.5mm cortex screw self-tapping 20mm.This is report 4 of 10 for (b)(4).This (b)(4) captures the post-op event involving the hardware removal due to pain, while (b)(4) was created to capture the intra-op event involving the unknown screws that was left in the patient's body.

• 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: 8686860
• Report Number: 2939274-2019-58590
• Device Sequence Number: 19426308
• Product Code: HWC
• UDI-Device Identifier: 10886982146281
• UDI-Public: (01)10886982146281
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2019

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: 204.820
• Device Catalogue Number: 204.820
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR