MAUDE Adverse Event Report: STRYKER TRAUMA KIEL G&K FEM NAIL EXTRACTION; INSTRUMENT

Catalog Number 11111000

Device Problem Difficult to Remove (1528)

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

Event Date 08/26/2016

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.

Event Description

It was reported that the patient underwent the surgery with the ap-j nail.On (b)(6) 2016, the patient underwent the ap-j extract surgery due to osteoarthritis and to convert to tha.The surgeon used the extraction adapter for ap-j.However the surgeon did not extracted the nail.When the surgeon checked the adapter, he found that it is another adapter (1111-1100).Therefore the surgeon used the adapter for gamma3.He extracted the nail and canceled tha.This adapter was shipped from our distribution center.Tha was cancelled because the nail removal took time.

• Brand Name: G&K FEM NAIL EXTRACTION
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5971760
• MDR Text Key: 55695665
• Report Number: 0009610622-2016-00443
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2016

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: Health Professional
• Device Catalogue Number: 11111000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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