MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; INSTRUMENT

Catalog Number UNK_REC

Device Problem Device Inoperable (1663)

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

Event Date 06/01/2015

Event Type  malfunction  

Event Description

During a primary hip procedure, surgeon mentioned that the reamers sizes 48, 49, 50 were not cutting, they were merely polishing.Sales rep stated to staff to take reamers out of service.Another set of reamers was on hand and used to complete the case without delay/incident.

Manufacturer Narrative

Catalog number unknown at this time.Device description reported as unknown #48 reamer.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

During a primary hip procedure, surgeon mentioned that the reamers sizes 48, 49, 50 were not cutting, they were merely polishing.Sales rep stated to staff to take reamers out of service.Another set of reamers was on hand and used to complete the case without delay/incident.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4869564
• MDR Text Key: 21182474
• Report Number: 0002249697-2015-02073
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: No
• 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): Other