MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI STERNAL LOCKING X PLATE WIDE/10 HOLES; PLATE, FIXATION, BONE

Model Number	460.040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930); No Code Available (3191)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional pro-code: hwc, jdq.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary - 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 or Problem Description
It was reported that on (b)(6) 2019, the surgeon removed the implanted five(5) sternal plates and thirty-two (32) sternal screws into patient due to non-union sternum following a sternotomy.Date of implantation was on (b)(6) 2019.At time of implantation, physician was happy with how screws had purchased and checked multiple times the reduction and tactile strength of the fixation along the sternum.The sales consultant was informed via phone call on (b)(6) 2019, that patient's plates and screws had dehiscence through the bone and had become infected.Physician did not think that this infection was caused by the implants, but more by a patient's compliance and past history.All thirty-two (32) screws and five (5) plates were removed from the patient on (b)(6) 2019, with no complications and no product issue or malfunction.Procedure was successfully completed.Patient status is unknown.This complaint involves ten (10) devices.This report is for one (1) ti sternal locking x plate wide/10 holes.This report is 5 of 10 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.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.Date of event corrected to (b)(6) 2019.
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.Date rec¿d by mfr : date updated to april 29, 2019.

• Brand Name: TI STERNAL LOCKING X PLATE WIDE/10 HOLES
• 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: 8553119
• Report Number: 2939274-2019-57677
• Device Sequence Number: 16235199
• Product Code: HRS
• UDI-Device Identifier: 10887587055213
• UDI-Public: (01)10887587055213
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K093772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2019

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
• Operator of Device: Health Professional
• Device Model Number: 460.040
• Device Catalogue Number: 460.040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 04/29/2019; 04/29/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 05/28/2019; 05/28/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR