MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO BATTERY; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 4115000000

Device Problem Disassembly (1168)

Patient Problem No Patient Involvement (2645)

Event Date 06/26/2015

Event Type  malfunction  

Manufacturer Narrative

The device was scrapped by stryker.

Event Description

It was reported during service at manufacturer facility that housing appears to be melted near the guide rails and there are chips on the housing near the weld area.This event occurred during service therefore there is no patient involvement, no delay, no medical intervention and no adverse consequences.

• Brand Name: BATTERY
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 5396375
• MDR Text Key: 36998627
• Report Number: 0001811755-2016-00100
• Device Sequence Number: 1
• Product Code: KIJ
• 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
• Report Date: 06/26/2015

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: Other
• Device Catalogue Number: 4115000000
• Device Lot Number: 15007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2015
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2015
• 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