MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 105/100; TRIGEN INTERTAN

Catalog Number 71677105

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 02/02/2016

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 that the patient had removal of hardware, which was replaced with shorter screws in the left hip.

Manufacturer Narrative

Additional information: the associated complaint device was not returned.A visual inspection of the product could not confirm the stated failure without obtaining the actual device/ product.A review of complaint history revealed no prior complaints for listed part/failure mode, no prior complaints for the listed lot.A review of the manufacturing records did not reveal any abnormalities that could have contributed to the reported issue.An attempted clinical analysis indicated that it was reported via medwatch that a patient had a removal of hardware, which was replaced with shorter screws in the left hip.There is no information regarding the need for the hardware removal.Additionally, there are no radiographs, patient clinical/medical records provided.Based on the lack of information, no clinical assessment can be performed.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: LAG/COMP SCREW KIT 105/100
• Type of Device: TRIGEN INTERTAN
• 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: 5615134
• MDR Text Key: 43888463
• Report Number: 1020279-2016-00358
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• PMA/PMN Number: K040212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2024
• Device Catalogue Number: 71677105
• Device Lot Number: 14AT38003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2014
• 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; Required Intervention