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

Catalog Number 7126120000

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2016

Event Type  malfunction  

Event Description

The sales rep reported that the housing came apart.The housing opening could expose the non-sterile battery to the sterile field.There were no adverse consequences, medical intervention or delays.

Manufacturer Narrative

The reported event was not duplicated.The service technician observed the o-ring was larger than expected and it was difficult to close the battery housing.A larger than expected o-ring can cause or contribute to a difficulty in closing the battery housing but would not cause or contribute to the reported event.

Event Description

The sales rep reported that the housing came apart.The housing opening could expose the non-sterile battery to the sterile field.There were no adverse consequences, medical intervention or delays.A loose o-ring was detected during service.

• Brand Name: SMARTLIFE LARGE ASPETIC 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: 5967632
• MDR Text Key: 55319164
• Report Number: 0001811755-2016-02328
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2016

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: 7126120000
• Device Lot Number: 15230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2016
• Initial Date FDA Received: 09/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2015
• 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