MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM SELF-DRILLING SCHANZ SCREW 80MM THRD/200MM; SCREW, FIXATION, BONE

Model Number	294.786
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id/case reported as #(b)(4).Infection occurred on unknown date between (b)(6) 2018 and (b)(6) 2018.Additional procode: ktt.Lot number is unknown.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 (b)(6) 2018, the patient underwent removal of exfix schanz pin from the proximal one-third of the femur due to an infected pin site.The patient was originally implanted with the pin on (b)(6) 2018.The pin site was cleaned and a new pin was placed on a different site.The procedure was successfully completed with no surgical delay reported.This report is for a 5.0mm self-drilling schanz screw 80mm thrd/200mm.This is report 1 of 1 for (b)(4).

• Brand Name: 5.0MM SELF-DRILLING SCHANZ SCREW 80MM THRD/200MM
• 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: 7611419
• Report Number: 2939274-2018-52530
• Device Sequence Number: 16526403
• Product Code: HWC
• UDI-Device Identifier: 10886982182197
• UDI-Public: (01)10886982182197
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2018

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: 294.786
• Device Catalogue Number: 294.786
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Weight: 72