MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ELITE COMP IMPL KIT 15X15X15 2 LEGS; STAPLE, FIXATION, BONE

Model Number	EL-1515S2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in the usa as follows: it was reported that the patient was operated on (b)(6) 2021.They had a wright medical wedge and a synthes cci staple 15 mm placed for a lateral lengthening or evans osteotomy.The patient appeared to not heal and broke the cci.They revised the non union site with pliafx, and new 4 leg cci.Part numbers involved in the definitive surgery.Surgery was completed successfully.No fragments left in patient.I might have the broken part for return i¿m checking.This complaint involves one(1) device elite comp impl kit 15x15x15 2 legs.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: 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.
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.H10 additional narrative: g4.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: ELITE COMP IMPL KIT 15X15X15 2 LEGS
• Common Device Name: STAPLE, 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 13995008
• Report Number: 2939274-2022-01173
• Device Sequence Number: 4432406
• Product Code: JDR
• UDI-Device Identifier: 00810633021675
• UDI-Public: (01)00810633021675
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K150125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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: EL-1515S2
• Device Catalogue Number: EL-1515S2
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELITE COMP IMPL DRILL KIT 3.0 DRILL BIT; ELITE COMPRESSION IMPL DRILLING TEMPLS; ELTE COMP IMPL KIT 25X20X20X20X20 4 LEGS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown