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

Catalog Number 4126120000

Device Problems Disassembly (1168); Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 04/01/2014

Event Type  malfunction  

Event Description

It was reported that the aseptic housing fractured and detached from the top housing to the aseptic bottom housing where battery is placed during inspection at user facility.No associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The reported event, housings disassembled, could not be confirmed as the battery housings were not available for evaluation.Based on a review of previous cases with a similar reported event and risk documentation, the most likely cause of the failure could be due to improper insertion of the batteries into the battery housings or they were damaged due to impact.Device is scrapped by the customer.

• Brand Name: ASEPTIC BATTERY HOUSING
• 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: 3799002
• MDR Text Key: 4479820
• Report Number: 0001811755-2014-01655
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K972367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4126120000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1