MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PLATE,FIXATION,BONE

Device Problem No Apparent Adverse Event (3189)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Initial reporter is synthes representative.510k: this report is for an unknown plates: tibia /unknown lot.Part and lot numbers are unknown; udi number is unknown.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 Description

It was reported that on (b)(6) 2016, a patient underwent a bilateral hardware removal of unknown expert tibial nail, locking compression plate (lcp) distal tibial plate, expert a2fn nail, and screws due to increased pain with swelling.While removing the implants, the healthcare providers located a cyst type body in the patient¿s right leg that was sent for culture, and the result revealed positive for infection.On or around (b)(6) 2015, the patient underwent an open reduction and internal fixation (orif) of the right tibial shaft and was implanted with an unknown lcp distal tibial plate, unknown expert a2fn nail and unknown screws.The patient was also implanted with an unknown expert tibial nail and unknown screws in the left tibial shaft.The implants were implanted due to a sustained right and left tibia shaft fractures.On or about (b)(6) 2016, the patient experienced significant pain in the left tibia that began to increase with swelling, and a swollen and painful right tibia while he was in a church.The patient sought medical attention early in (b)(6) 2016 and the healthcare providers found a fracture of an interlocking screw on an x-ray result but suggested to wait for a revision surgery in the event the symptoms would resolve on their own.The symptoms did not resolve on their own and the patient continued to seek medical care.The patient underwent a revision surgery in (b)(6) 2017 and was implanted with an unknown device.This report is for one (1) plates: tibia.This is report 2 of 5 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

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.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

This is report 2 of 6 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.H10 additional narrative: b6: updated test/lab information.B7: updated medical information.G3: updated source.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.

• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8439985
• MDR Text Key: 139536788
• Report Number: 2939274-2019-57065
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/26/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 11/25/2019; 01/23/2020; 02/06/2020
• Supplement Dates FDA Received: 11/27/2019; 01/23/2020; 02/07/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR