MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO DISPOSABLE CEMENT SCULPS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 0206716000

Device Problem Flaked (1246)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2014

Event Type  malfunction  

Event Description

It was reported that during a total knee procedure, while removing excess cement from around the implant, the disposable cement sculps were found to be flaking off.The procedure was completed successfully utilizing back-up equipment.No delay, no medical intervention and no adverse consequences were reported with this event.

Event Description

It was reported that during a total knee procedure, while removing excess cement from around the implant, the disposable cement sculps were found to be flaking off.The procedure was completed successfully utilizing back-up equipment.No delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

A follow up report will be filed after the quality investigation has been completed.

Manufacturer Narrative

Upon visual inspection, the edges on the sculp area were found to be slightly jagged.The device was discarded by the manufacturer.

• Brand Name: DISPOSABLE CEMENT SCULPS
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 0061 5
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 0061 5
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3786454
• MDR Text Key: 4361491
• Report Number: 0001811755-2014-01590
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0206716000
• Device Lot Number: 14037012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2014
• Initial Date FDA Received: 05/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2014
• 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