MAUDE Adverse Event Report: SMITH & NEPHEW, INC. D-RAD TI 2.4MM X 12MM CTX SCR T7 S-T; D-RAD SMART PACK

Catalog Number 74682412

Device Problem Device Expiration Issue (1216)

Patient Problem No Information (3190)

Event Date 01/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

It was reported a product past its expiration date was implanted.

Manufacturer Narrative

The associated device/packaging was not returned for evaluation.A review of manufacturing records revealed that the sterilization date on the label was printed correctly.The label accurately represented the expiration date as 12/15; the device was implanted (b)(6).No further investigation is warranted at this time.

• Brand Name: D-RAD TI 2.4MM X 12MM CTX SCR T7 S-T
• Type of Device: D-RAD SMART PACK
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: yagna angirish ; 1450 brooks rd; memphis, TN 38116 ; 9013995009
• MDR Report Key: 5396137
• MDR Text Key: 36987735
• Report Number: 1020279-2016-00083
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2015
• Device Catalogue Number: 74682412
• Device Lot Number: 13MM12404A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other