MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 16MM; SCREW, FIXATION, BONE

Model Number	204.816
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: hrs and 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.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 an unknown date, during an unknown surgery, locking compression plate, cortex screws, and locking screws were taken out due to patient pain.It is unknown if there was a surgical delay.Procedure outcome and patient status are unknown.Concomitant devices reported: 2.7mm cortex screw self-tapping 16mm (part number 202.816, lot unknown, quantity 1) 2.7mm/3.5mm va-lcp lat ant clavicle plate/11h/113mm (part number 02.112.048, lot unknown, quantity 1); 3.5mm locking screw slf-tpng w/stardrive(tm) recess 16mm (part number 212.104, lot unknown, quantity 1); 3.5mm cortex screw self-tapping 14mm (part number 204.814, lot unknown, quantity 1); 2.7mm va lckng screw slf-tpng with t8 stardrive recess 16mm (part number 02.211.016, lot unknown, quantity 1); 3.5mm cortex screw self-tapping 16mm (part number 204.816, lot unknown, quantity 1); 2.7mm va lckng screw slf-tpng with t8 stardrive recess 16mm (part number 02.211.016, lot unknown, quantity 1).This report involves one (1) 3.5mm cortex screw self-tapping 16mm.This is report 2 of 8 for (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 16MM
• 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: 11163145
• Report Number: 2939274-2021-00236
• Device Sequence Number: 845785
• Product Code: HWC
• UDI-Device Identifier: 10886982146267
• UDI-Public: (01)10886982146267
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

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: 204.816
• Device Catalogue Number: 204.816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 01/13/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.7MM CORTEX SCREW SELF-TAPPING 16MM; 2.7MM VA LCKNG SCREW SLF-TPNG; 2.7MM VA LCKNG SCREW SLF-TPNG; 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE; 3.5MM CORTEX SCREW SELF-TAPPING 14MM; 3.5MM CORTEX SCREW SELF-TAPPING 16MM; 3.5MM LOCKING SCREW SLF-TPNG
• Outcome Attributed to Adverse Event: Required Intervention