MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/14H/RIGHT/239MM; PLATE, FIXATION, BONE

Model Number	02.112.530
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is an unknown date in (b)(6) 2018.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A device history record review has been requested.(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) 2018, the patient underwent open reduction internal fixation (orif) of the ankle.The open distal tibia fracture was plated with one (1) medial distal tibia plate and one (1) locking compression plate (lcp) plate.The fibula was also plated with a one-third (1/3) tubular plate.The patient had an infection due to the open fracture and was made aware on (b)(6) 2018.Action taken was irrigation and debridement.Hardware removal occurred on (b)(6) 2018.The procedure was completed successfully with no delay.This report is for a 3.5mm lcp distal tibia plate.This is report 1 of 4 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.A device history record (dhr) review is not required as the complaint pertains to a post-operative infection and is distributed as non-sterile.Device evaluation: investigation flow: adverse event (no reported product problem) visual inspection: the returned device was examined and minor wear/surface abrasions consistent with implantation and explantation were noted; the received condition would not impact the device functionality.No defects or deficiencies were identified.The allegation of adverse event (infection) cannot be confirmed.Conclusion: the received device was found to be without defect or deficiency which would impact functionality.During this investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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) 2018, the patient underwent open reduction internal fixation (orif) of ankle due to an injury.The open distal tibia fracture was plated with one (1) medial distal tibia plate and one (1) locking compression plate (lcp) plate.The fibula was also plated with one (1) one-third (1/3) tubular plate.The patient had an infection due to the open fracture and was made aware on (b)(6) 2018.A hardware removal was conducted on (b)(6) 2018 for all plates including one (1) 3.5mm locking screw self-taping with stardrive(tm) recess 50mm, one (1) 3.5mm locking screw self-taping with stardrive recess 48mm, one (1) locking screw self-taping with stardrive recess 42mm, one (1) 3.5mm locking screw self-taping with stardrive(tm) recess 40mm, one (1) 3.5mm locking screw self-taping with stardrive(tm) recess 18mm, two (2) 2.7mm cortex screw self-tapping 32mm, one (1) 2.7mm cortex screw self-tapping 36mm, two (2) 3.5mm cortex screw self-tapping 38mm, one (1) 3.5mm cortex screw self-tapping 36mm, one (1) 3.5mm cortex screw self-tapping 34mm, five (5) 3.5mm cortex screw self-tapping 32mm, and one (1) 3.5mm cortex screw self-tapping 30mm.Irrigation and debridement was performed during removal surgery.There was no surgical delay.Procedure outcome was successfully completed.Patient outcome is unknown.This report is for one (1) 3.5mm lcp low bend medial dstl tibia plate/14h/right/239mm.This is report 1 of 10 for (b)(4).(b)(4) captures 10 devices out of 26 and houses 10 impacted products of the 17 unique part and lot number devices.(b)(4) captures 10 devices and (b)(4) captures 6 devices.
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.
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 LCP LOW BEND MEDIAL DSTL TIBIA PLATE/14H/RIGHT/239MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8180194
• Report Number: 2939274-2018-55470
• Device Sequence Number: 19312999
• Product Code: HRS
• UDI-Device Identifier: 10886982034670
• UDI-Public: (01)10886982034670
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K013248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/27/2018

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
• Operator of Device: Health Professional
• Device Model Number: 02.112.530
• Device Catalogue Number: 02.112.530
• Device Lot Number: H338255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 11/27/2018; 12/20/2018; 01/07/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 12/19/2018; 12/22/2018; 01/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention