MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_DRILL BIT; KNEE INSTRUMENT

Catalog Number UNK_REC

Device Problems Mechanical Problem (1384); Sticking (1597); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2016

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

During a primary right total knee procedure the drill became cold welded/stuck in hole of cutting block.Lot number was not available.No adverse patient consequences and no delay in surgery.Procedure was complete using another cutting block.

Manufacturer Narrative

An event regarding alleged seizing involving an unknown drill was reported.The event was confirmed.It is jammed into the distal resection guide.There spiral scratches around the base of the drill bit.Medical records received and evaluation: no patient medical records were available for review.Device history review: a review of the device history records could not be performed as no lot information was provided.Complaint history review: a complaint history review could not be performed as no lot information was provided.The investigation concluded by a discussion with a member of the mar group found the drill bit became stuck within the guide was due to galling which occurred during use.

Event Description

During a primary right total knee procedure the drill became cold welded/stuck in hole of cutting block.Lot number was not available.No adverse patient consequences and no delay in surgery.Procedure was complete using another cutting block.

• Brand Name: UNKNOWN_DRILL BIT
• Type of Device: KNEE 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5652424
• MDR Text Key: 45137040
• Report Number: 0002249697-2016-01591
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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