MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS-32MM; SCREW, FIXATION, BONE

Model Number	201.782
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: hrs.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 that on an unknown date, the patient had post-op infection.The patient received the implants on (b)(6) 2020.On (b)(6) "20201" the implants were removed.The removal procedure was completed successfully.Patient outcome is unknown.Concomitant devices reported: 2.4mm cortex screw slf-tpng with t8 stardrive recess-34mm (part number 201.784, lot unknown, quantity 1), 2.7mm va-locking calcaneal plate large 70mm left (part number 02.211.405, lot unknown, quantity 1), 2.7mm metaphyseal scr slf-tpng w/t8 strdrv recess/38mm (part number 02.118.538, lot unknown, quantity 1), 2.7mm metaphyseal scr slf-tpng w/t8 strdrv recess/34mm (part number 02.118.534, lot unknown, quantity 1), 2.7mm metaphyseal scr slf-tpng w/t8 strdrv recess/40mm (part number 02.118.540, lot unknown, quantity 1), 2.7mm metaphyseal scr slf-tpng w/t8 strdrv recess/32mm (part number 02.118.532, lot unknown, quantity 1), 2.7mm va lckng screw slf-tpng with t8 stardrive recess 34mm (part number 02.211.034, lot unknown, quantity 1), 2.7mm va lckng screw slf-tpng with t8 stardrive recess 30mm (part number 02.211.030, lot unknown, quantity 1), 2.7mm metaphyseal scr slf-tpng w/t8 strdrv recess/36mm (part number 02.118.536, lot unknown, quantity 1).This report involves one (1) 2.4mm cortex screw slf-tpng with t8 stardrive recess-32mm.This is report 2 of 10 for (b)(4).This product complaint is related to (b)(4).
Event or Problem Description
On (b)(6), 2020 the implants were removed.
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.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.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.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: 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS-32MM
• 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: 11224278
• Report Number: 2939274-2021-00449
• Device Sequence Number: 17203172
• Product Code: HWC
• UDI-Device Identifier: 10886982142849
• UDI-Public: (01)10886982142849
• 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
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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: 201.782
• Device Catalogue Number: 201.782
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 02/16/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.4MM CORTEX SCREW 34MM; 2.7MM META2.7MM VA LCKNG SCREW 32MM; 2.7MM METAPHYSEAL SCR 32MM; 2.7MM METAPHYSEAL SCR 34MM; 2.7MM METAPHYSEAL SCR 36MM; 2.7MM METAPHYSEAL SCR 38MM; 2.7MM METAPHYSEAL SCR 40MM; 2.7MM VA LCKNG SCREW 34MM; 2.7MM VA-LOCK CALCANEAL PL LARGE 70MM L
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR