MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII FEM LOCK IMPL IMPACTR; KNEE INSTRUMENT

Catalog Number 71440490

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 04/16/2015

Event Type  Injury  

Event Description

The impactor used during surgery fell apart on impaction and a screw from the broken device fell inside the wound.The procedure was extended by two hours due in order to retrieve the displaced screw from the patient.

Manufacturer Narrative

Manufacturer Narrative

The associated device was returned and evaluated.The visual inspection of the returned device confirms that the impactor is broken in many pieces.All pieces were returned.A review of the complaint history shows prior complaints for the listed failure mode but none for the listed lot.Our investigation did not determine the specific cause of the damage; however, the device was manufactured in 2003.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This investigation could not verify or identify any evidence of product contribution to the reported problem.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: GII FEM LOCK IMPL IMPACTR
• Type of Device: KNEE INSTRUMENT
• 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: 4742493
• MDR Text Key: 16880675
• Report Number: 1020279-2015-00232
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71440490
• Device Lot Number: 03EM00524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2015
• Initial Date FDA Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention