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

Catalog Number	7126120000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the housing fractured.The broken housing could cause the non-sterile battery to be exposed to the sterile field.Attempts are being made for additional information.
Additional Manufacturer Narrative
The reported event was confirmed.A picture was provided at intake and it was visually observed the housing's weld was fractured.
Event or Problem Description
The user facility reported that the housing fractured.The broken housing could cause the non-sterile battery to be exposed to the sterile field.Although requested, no information was available regarding patient involvement, adverse consequences, surgical delay or medical intervention.

• Brand Name: SMARTLIFE LARGE ASPETIC HOUSING
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 20334220
• Report Number: 3015967359-2024-01859
• Device Sequence Number: 9727956
• Product Code: HWE
• UDI-Device Identifier: 07613327128819
• UDI-Public: (01)07613327128819(10)19144
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 7126120000
• Device Lot Number: 19144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown