MAUDE Adverse Event Report: ZIMMER SURGICAL OSC GTS LHPP 105 X 19 X 1.27 MM; OSC GT LHPP 105 X 19 X 1.27 MM

Catalog Number 19105127LG1

Device Problems Break (1069); Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2015

Event Type  malfunction  

Event Description

It was reported that during the surgery, the blade's hub broke and the blade disconnected from the handpiece.The blade was recovered from the nurses.Additional clinical information obtained indicated that during the femoral cut, the customer decided to change the blade (as surgical technique).When the blade was removed from the handpiece, it was noticed that the blade's hub was broken.The blade was replaced with another blade manufactured by zimmer; however the information regarding the part number and lot number of the replacement blade was not available.The personal cutting guide, size 7m was used with the blade along with a linvatec handpiece; however the model number of the handpiece was not provided.It was confirmed that the blade was not reprocessed.The blade was discarded by the nurse.There was no patient/user harm or surgical delay reported.No medical intervention was associated with this report.No additional clinical information was received prior to this report.

Manufacturer Narrative

The review of manufacturing records for part #11-4515-01/customer part #19105127lg1, lot #28439 showed that there were no non-conformances during manufacture of the device.No product was returned by the customer for evaluation.The root cause of the complaint could not be determined.

• Brand Name: OSC GTS LHPP 105 X 19 X 1.27 MM
• Type of Device: OSC GT LHPP 105 X 19 X 1.27 MM
• Manufacturer (Section D): ZIMMER SURGICAL; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: 200 west ohio avenue; dover, OH 44622 ; 8003215533
• MDR Report Key: 4627862
• MDR Text Key: 5764031
• Report Number: 2950261-2015-00003
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 19105127LG1
• Device Lot Number: 2W040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1