MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INT HEX RC SCR BL 6.4X100; NAIL, FIXATION, BONE

Catalog Number 71642300

Device Problem Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 01/16/2018

Event Type  Injury  

Event Description

Revision/exchange trigen blue 6.4mm recon screws due to backing out and penetration acetabulum.Right femur.

Manufacturer Narrative

The associated complaint devices were not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A clinical analysis indicated that based on the provided information a definitive root cause of the reported issue cannot be determined.No further clinical assessment is able to be performed.A review of complaint history on the listed part revealed no additional complaints for the listed batches.Without the actual product involved 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.We consider this investigation closed.

• Brand Name: INT HEX RC SCR BL 6.4X100
• Type of Device: NAIL, FIXATION, BONE
• 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: markus poettker ; 1450 brooks road; memphis, TN
• MDR Report Key: 7224073
• MDR Text Key: 98405345
• Report Number: 1020279-2018-00083
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 03596010496959
• UDI-Public: 03596010496959
• Combination Product (y/n): N
• PMA/PMN Number: K981529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 71642300
• Device Lot Number: 15CM09460
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR