MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DISTAL TIP EXTRACTOR. INCLUDES; INSTRUMENT

Catalog Number 1117-0000JP

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/04/2014

Event Type  malfunction  

Event Description

During the revision surgery of omniflex hip, distal tip was remained in the femoral canal.Then the surgeon tried to extract the distal tip with the tip remover, the distal part of remover was broken.

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

Material analysis indicated the device fractured due to overload.The investigation determined the likely root cause of the event to be back impaction of the knob which overloaded the component and resulted in fracture.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.Visual inspection: the returned device is in used condition with minor damages consistent with normal use.The knob is fractured from the proximal end of the device.If additional information becomes available, this investigation will be reopened.

Event Description

During the revision surgery of omniflex hip, distal tip was remained in the femoral canal.Then the surgeon tried to extract the distal tip with the tip remover, the distal part of remover was broken.

• Brand Name: DISTAL TIP EXTRACTOR. INCLUDES
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3973508
• MDR Text Key: 4612414
• Report Number: 0002249697-2014-02973
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/15/2014

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: Health Professional
• Device Catalogue Number: 1117-0000JP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/15/2014
• Initial Date FDA Received: 08/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: No
• 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