MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: CORTEX; SCREW,FIXATION,BONE

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.510k: this report is for an unknown screw: cortex/unknown lot.Part and lot numbers are unknown; udi 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 Description

It was reported that on (b)(6) 2019 the patient underwent a revision surgery of the left proximal femur due to a nonunion after a synthes capos blade plate was implanted on an unknown date.The osteotomy has gone into a nonunion.The capos blade plate was removed.All three (3) unknown 4.5 mm cortex screws were broke.One (1) of the three (3) screw fragments was removed.The remaining screw fragments remain in the femur.The plate was removed intact.The osteotomy was cleaned up to bleeding bone and secured with a synthes 130 degree angled blade plate.The procedure was successfully completed.Patient status was unknown.Concomitant device: adolescent osteotomy plate (part #: 235.721, lot #: unknown, quantity #: 1).This report is for one (1) unk - screws: cortex: trauma.This is report 3 of 3 for (b)(4).

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.

Event Description

It was further reported that three (3) unknown 4.5 mm cortex screw were already broken prior to revision surgery.

• Brand Name: UNK - SCREWS: CORTEX
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9311164
• MDR Text Key: 183708857
• Report Number: 2939274-2019-62114
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2019
• Patient Sequence Number: 1
• Treatment: 100 DEG ADOLESCENT OSTEOTOMY PLATE 60MM/15MM
• Patient Outcome(s): Required Intervention