MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0 SELF-DRILL SCHZ SCR 200/HA COATING-S; APPLIANCE,FIXATION,NAIL

Model Number	294.786SHA
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)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Patent identifier: (b)(6).Additional product code: hwc 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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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.
Event or Problem Description
It was reported on (b)(6) 2021, the patient underwent removal of infected pin self drill schanz screw hydroxyapatite (ha) coating.The pin was removed.The patient was okay.This complaint involves one (1) device.This report is for (1) 5.0 self-drill schz scr 200/ha coating-s.This report is 1 of 1 for (b)(4).

• Brand Name: 5.0 SELF-DRILL SCHZ SCR 200/HA COATING-S
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12481872
• Report Number: 2939274-2021-05467
• Device Sequence Number: 17366368
• Product Code: KTT
• UDI-Device Identifier: 10886982182210
• UDI-Public: (01)10886982182210
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K161417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 08/19/2021

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: 294.786SHA
• Device Catalogue Number: 294.786SHA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/16/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention