MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5 TI CORTEX SCR SLF-TPNG T4 SD REC 10; SCREW,FIXATION,BONE

Model Number	04.214.110
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: 510k: this report is for an unknown screws: cortex: trauma/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.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) 2022, during an open reduction and internal fixation (orif) finger.When implanting a 1.5 titanium cortex screw from the va handset it stripped and was difficult to remove.The surgeon stripped two t4 screwdrivers while attempting to remove the screw.They are now warped and unable to use.The screw was going to be removed because it had no purchase in the bone.The procedure was successfully completed but there was a surgical delay of 10 minutes.The procedure was completed.This report involves one (1) unknown screws: cortex: trauma.This is report 3 of 3 for (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.D2b: additional device product codes: hsb.D4: catalog and udi.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: 1.5 TI CORTEX SCR SLF-TPNG T4 SD REC 10
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13768972
• Report Number: 2939274-2022-00876
• Device Sequence Number: 19825157
• Product Code: HWC
• UDI-Device Identifier: 10886982120854
• UDI-Public: (01)10886982120854
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.214.110
• Device Catalogue Number: 04.214.110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SD SCRWDRVR SHFT/T4 50/SELF-RETAIN/HXC; SD SCRWDRVR SHFT/T4 50/SELF-RETAIN/HXC
• Patient Sex: Male