MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 60MM; SCREW,FIXATION,BONE

Model Number	204.860
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 2019, the patient underwent hardware removal due to the cortex screw self-tapping 60mm that was used as a syndesmosis screw that was broke.The screw shaft remained in the tibia.Original implantation date was on (b)(6) 2018.It is unknown if there was surgical delay.Procedure and patient outcome was unknown.Concomitant device reported: unknown plate (part # unknown, lot # unknown, quantity # 1), unknown long cortical screw (part # unknown, lot # unknown, quantity # 1).This report is for one (1)- 3.5mm cortex screw self-tapping 60mm.This is report 1 of 1 for (b)(4).
Event or Problem Description
The patient came back post-op and xrays determined the screw was broken.During removal, the broken head of the screw and another long cortical screw that was also used as a syndesmotic screw were all 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.

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 60MM
• 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: 8620086
• Report Number: 2939274-2019-58128
• Device Sequence Number: 18906184
• Product Code: HWC
• UDI-Device Identifier: 10886982146502
• UDI-Public: (01)10886982146502
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 204.860
• Device Catalogue Number: 204.860
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 06/14/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK LONG CORTICAL SCREW; UNKNOWN - PLATE; UNK LONG CORTICAL SCREW; UNKNOWN - PLATE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 154