MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) TRD, STANDARD, ASSY,STRL SYNTHES; CERCLAGE FIXATION

Model Number	401-033
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is a follow-up to an already existing report.The distributor of this product incorrectly has identified theirself as the manufacturer of this device and submitted report number, 2939274-2019-62136, on their behalf.The device was not returned to rti surgical for evaluation.A dhr review was conducted and confirms the device met manufacturing specification prior to shipping from rti surgical facility.This report will be updated should information become available at a later date.Patient identifier, age or date of birth, sex, weight, ethnicity, race, implant date, explant date have been left blank as this information could not be obtained in this investigation.
Event or Problem Description
It was reported to rti surgical on (b)(6) 2020 that there was a patient who underwent a revision on an unknown date due to 2 stage infection related to a previous hip surgery.It is unknown when index surgery was performed.

• Brand Name: TRD, STANDARD, ASSY,STRL SYNTHES
• Common Device Name: CERCLAGE FIXATION
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette, mi
• MDR Report Key: 9689372
• Report Number: 1833824-2020-00013
• Device Sequence Number: 19746473
• Product Code: JDQ
• UDI-Device Identifier: 10886982236975
• UDI-Public: (01)10886982236975(17)210731(10)P252359
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K001709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2020

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 Expiration Date: 07/31/2021
• Device Model Number: 401-033
• Device Catalogue Number: 498.806S
• Device Lot Number: P252359
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention