MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOUR UNI TIBIAL CUT BLK RT; ORTHOPAEDIC SURGICAL INSTRUMENTATION

Catalog Number 71441336

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Code Available (3191)

Event Date 04/17/2014

Event Type  Injury  

Event Description

It was reported that the or staff experienced difficulties with the assembly of mating instruments.Surgery time was extended beyond 30 minutes.

Manufacturer Narrative

The associated devices were returned and evaluated.A functional assessment of the devices noted that there was a tight fit between the alignment rod and tube, but no issues were noted between the complained features of the rod and cutting block.Subsequently, a dimensional inspection was performed on applicable features of current inventory.All current inventories checked were found to be within design specifications.A review of manufacturing records of the complaint devices did not reveal any discrepancies that could have contributed to this issue.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: JOUR UNI TIBIAL CUT BLK RT
• Type of Device: ORTHOPAEDIC SURGICAL INSTRUMENTATION
• 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: lisa hassell ; 1450 brooks road; memphis, TN 38116 ; 9013991128
• MDR Report Key: 3792507
• MDR Text Key: 4523815
• Report Number: 1020279-2014-00299
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,hea
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71441336
• Device Lot Number: 08GM11572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(4)
• Patient Outcome(s): Hospitalization