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

Catalog Number 7222120000

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

Patient Problem No Patient Involvement (2645)

Event Date 04/01/2015

Event Type  malfunction  

Event Description

It was reported that during testing conducted at the manufacturer facility, the latch on the battery housing was broken.As a result, the device would not lock closed, with the potential to expose a non-sterile battery to a surgical site.

Manufacturer Narrative

The reported event, housing will not lock as latch is broken, was duplicated.Service evaluation determined that the housing would not lock.The latch was broken on the bottom housing, which was physically cracked.The housing area where the latch was attached was broken off.As this is not a repairable device, it was not returned to the customer.

Event Description

It was reported that during testing conducted at the manufacturer facility, the latch on the battery housing was broken.As a result, the device would not lock closed, with the potential to expose a non-sterile battery to a surgical site.

Manufacturer Narrative

Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.

• Brand Name: SMARTLIFE SMALL 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: 4732407
• MDR Text Key: 6009047
• Report Number: 0001811755-2015-01543
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 7222120000
• Device Lot Number: 13191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2013
• 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