MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DISTAL RESECTION GUIDE - STANDARD; INSTRUMENT

Catalog Number 6541-1-721

Device Problem Sticking (1597)

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

Event Date 12/19/2014

Event Type  malfunction  

Event Description

The customer reported via the sales rep that during a procedure when he went to remove the x-pin (1/8 drill 3170-0000) from the distal resection guide (6541-1-721), it became stuck within the guide.The customer reported that the two other drills were removed successfully and the x-pin drill was removed within the distal resection guide.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding a drill bit seizing in a resection guide involving a distal resection guide was reported.The event was confirmed during visual and material evaluations.Method and results: device evaluation and results: an analysis by the material analysis team determined that the cause of the seizure was galling of the outside diameter surface of the drill bit with the inside diameter of the resection guide.The reason for the galling could not be determined.Medical records received and evaluation: not performed because no patient clinical information was provided as there is no evidence to support the event was related to patient factors.Device history review: the reported device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events reported for this manufacturing lot.Conclusions: the investigation concluded that the cause of the event was the galling and seizing of the outside diameter surface of the drill bit with the inside diameter of the resection guide during use.The galling was confirmed by the material analysis team.The reason for the galling could not be determined.It was also concluded that there is no indication the event is related to a manufacturing issue.

Event Description

The customer reported via the sales rep that during a procedure when he went to remove the x-pin (1/8 drill 3170-0000) from the distal resection guide (6541-1-721), it became stuck within the guide.The customer reported that the two other drills were removed successfully and the x-pin drill was removed within the distal resection guide.

• Brand Name: DISTAL RESECTION GUIDE - STANDARD
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4412094
• MDR Text Key: 16186083
• Report Number: 0002249697-2015-00021
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2014

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: 6541-1-721
• Device Lot Number: SMM9K02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 01/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2014
• 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