MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 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 07/09/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure, the disposable cement sculps were found to be flaking.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The entire device is not being returned for evaluation; only the cement with the blue flakes are available as the customer has discarded the packaging and sculp.It is not possible to determine the cause of the reported malfunction without an evaluation of the entire device.The entire device is not being returned for evaluation.

• Brand Name: DISPOSABLE CEMENT SCULPS
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• 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: 3956691
• MDR Text Key: 19092942
• Report Number: 0001811755-2014-02657
• 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
• Report Date: 07/09/2014

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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/09/2014
• Initial Date FDA Received: 07/25/2014
• 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: Initial
• Patient Sequence Number: 1