MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 30MM; SCREW, FIXATION, BONE

Model Number	204.830
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date 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.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) 2020, a hardware removal was performed due to pain.It was noted one (1) broken screw was found during the revision surgery.This was not known prior to the surgery.All hardware was completely removed except a 2.7 mm variable angle locking screw.The head of the screw was removed but the shaft of it remained in the patient.The original implantation date was unknown.There was a surgical delay of one (1) minute.The procedure was successfully completed.This is report 3 of 3 for (b)(4).This complaint is linked to (b)(4).
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6: code 3191 used to capture surgical intervention and medical device removal.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: 3.5MM CORTEX SCREW SELF-TAPPING 30MM
• 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: 10620095
• Report Number: 2939274-2020-04445
• Device Sequence Number: 11372325
• Product Code: HWC
• UDI-Device Identifier: 10886982146335
• UDI-Public: (01)10886982146335
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2020

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: 204.830
• Device Catalogue Number: 204.83
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 10/29/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5MM CORTEX SCREW SELF-TAPPING 30MM.; 3.5MM CORTEX SCREW SELF-TAPPING 30MM.; 3.5MM CORTEX SCREW SELF-TAPPING 30MM; 3.5MM CORTEX SCREW SELF-TAPPING 30MM
• Outcome Attributed to Adverse Event: Required Intervention