MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ACET. CUP EXT. BLADE PACK 60MM; INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 7812060001K

Device Problem Break (1069)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 09/02/2016

Event Type  Injury  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.

Event Description

It was reported that during a surgical procedure, the blade snapped in half while the surgeon was trying to remove the blade from the patient.It was also reported that an unplanned x-ray was taken to locate the broken piece, it was not detected, the surgery continued.It was further reported that the broken piece was later located wedged between the cup and bone, the delay to surgery is unknown.It was also reported that the procedure was completed successfully.

Manufacturer Narrative

The blade was evaluated by the mechanical design engineer.Hardness was inspected on the returned sample and is reported to be within specification.From the analysis carried out, the blade was misused and cut against an obstructing object in the surgical site as well as a bending motion was being applied to the part against the inner diameter of the blade, as though it was being used off axis, and may have occurred due to overload bending conditions experienced with off axis cutting.The instructions for use (ifu) for the ezout acetabular cup removal system (7202-001-700) include warnings under the section to operate the handpiece that outline the user is not to apply excessive pressure in the form of bending, prying or excessive twisting, which may result in the bend or fracture of the blade or attachment.The ifu also contains a warning to always keep the device in line with the implanted cup axis and engaged with the plug while cutting.

Event Description

It was reported that during a surgical procedure, the blade snapped in half while the surgeon was trying to remove the blade from the patient.It was also reported that an unplanned x-ray was taken to locate the broken piece, it was not detected, the surgery continued.It was further reported that the broken piece was later located wedged between the cup and bone, the delay to surgery is unknown.It was also reported that the procedure was completed successfully.

• Brand Name: ACET. CUP EXT. BLADE PACK 60MM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA
• Manufacturer Contact: dervillia murphy ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 5986579
• MDR Text Key: 55896181
• Report Number: 0001811755-2016-02442
• 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: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7812060001K
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other