MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EXTENSION GUIDE BOLT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71654505
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during set up or inspection it was found that the rust is building up in two devices.The procedure finished with a smith and nephew backup device.No surgical delay.Patient injuries were not reported.Results of investigation of (b)(4) have concluded that this unit was rust which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that, after device evaluation, it was determined that the device was discolorated, not rust, and this failure mode is considered not reportable as it did not cause or contribute to a serious injury or death and it is not likely to cause or contribute to a serious injury or death if the malfunction were to recur; therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: EXTENSION GUIDE BOLT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11185585
• Report Number: 1020279-2021-00445
• Device Sequence Number: 11658466
• Product Code: HSB
• UDI-Device Identifier: 03596010585851
• UDI-Public: 03596010585851
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71654505
• Device Catalogue Number: 71654505
• Device Lot Number: 16DM04730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 11/12/2020; 01/28/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 01/28/2021; 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1