MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FOOTED ATTACHMENT 16MM; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number 5407FA2000

Device Problems Bent (1059); Overheating of Device (1437)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Twenty-one events were reported for this quarter.Twenty devices were received for evaluation; eighteen events were confirmed during testing.Eighteen devices were found to be bent.The reported event was not confirmed for 2 devices; the devices were found to be within specifications for the reported event.One device was not available to stryker for evaluation.This device is not repairable and was not returned to the user facility.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 21 malfunction events in which the device had a bent foot.Fifteen events had no patient involvement; no patient impact.Five events had patient involvement; no patient impact.One event had no known patient involvement or patient impact.

• Brand Name: FOOTED ATTACHMENT 16MM
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6981776
• MDR Text Key: 91239291
• Report Number: 0001811755-2017-02281
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 21
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2017

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: No Information
• Device Catalogue Number: 5407FA2000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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