MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI STERNAL LOCKING STAR PLATE 6 HOLES; PLATE,FIXATION,BONE

Model Number	460.035
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product codes hwc, jdq.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 or Problem Description
It was reported that on (b)(6) 2019, the patient underwent hardware removal from a chest wall due to infection.The surgeon removed one (1) titanium sternal locking star plate, one (1) titanium sternal locking x plate, and unknown screws.The parts that were removed were external reconstruction plates and screw.Along the reported plates the patient was implanted with the two (2) titanium sternal locking screw self-drilling/12mm, eighteen (18) titanium sternal locking screw self-drilling/14mm, five (5) titanium sternal locking screw self-drilling/16mm, and two (2) titanium sternal locking screw self-drilling/18mm.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.This report is for one (1) ti sternal locking star plate 6 holes this is report 1 of 10 for (b)(4).Due to a limit of impacted products per complaint, this complaint is a continuation from complaints (b)(4) for a total of twenty-nine (29) impacted products.
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.
Event or Problem Description
Update: april 10, 2019.The male patient was revised due to infection.All hardware was removed intact.The intervention after the removal of the implants is unknown.Along with the reported plates, the patient was implanted with the following devices: 04.501.112.01 qty.(2) titanium sternal locking screw self-drilling/12mm.04.501.114.01 qty.(18) titanium sternal locking screw self-drilling/14mm.04.501.116.01 qty.(5) titanium sternal locking screw self-drilling/16mm.04.501.118.01 qty.(2) titanium sternal locking screw self-drilling/18mm.
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: TI STERNAL LOCKING STAR PLATE 6 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: 8513965
• Report Number: 2939274-2019-57454
• Device Sequence Number: 16584814
• Product Code: HRS
• UDI-Device Identifier: 10887587055091
• UDI-Public: (01)10887587055091
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K093772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/20/2019

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: 460.035
• Device Catalogue Number: 460.035
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 04/10/2019; 05/17/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 05/09/2019; 05/17/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention