MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SMARTLIFE LARGE ASPTC HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 7126120000

Device Problems Fracture (1260); Device Disinfection Or Sterilization Issue (2909)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 08/31/2015

Event Type  Injury  

Manufacturer Narrative

The device has not been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.

Event Description

It was reported that the aseptic housing broke during a medical procedure and fell into the sterile field.The top housing detached from the bottom housing.The disassembly of the battery housing could result in potential exposure of a non-sterile battery to the surgical site.The patient was administered prophylactic antibiotics.The procedure was completed successfully using back-up equipment.No surgical delay or adverse consequences were reported.

Manufacturer Narrative

The reported event, the housing broke and fractured, was confirmed.During the inspection the service technician observed physical damage.The tech found that the top housing had separated from the bottom housing at the weld site.The battery housing was discarded by the manufacturer.

Event Description

It was reported that the aseptic housing broke during a medical procedure and fell into the sterile field.The top housing detached from the bottom housing.The disassembly of the battery housing could result in potential exposure of a non-sterile battery to the surgical site.The patient was administered prophylactic antibiotics.The procedure was completed successfully using back-up equipment.No surgical delay or adverse consequences were reported.

• Brand Name: SMARTLIFE LARGE ASPTC HOUSING
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-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: 5074302
• MDR Text Key: 25649941
• Report Number: 0001811755-2015-03342
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7126120000
• Device Lot Number: 14210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2014
• 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