MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN NAIL; IMPLANT

Catalog Number UNK_KIE

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Bacterial Infection (1735); Erythema (1840)

Event Date 01/10/2014

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.Investigation revealed the subject product to be a concomitant item.The device did not contribute to the event.According to information received the issue was noticed "during inform of recall" (b)(4) / guide wires and k-wires); the reported guide wires were suspected to have caused the infection.Product was disposed.

Event Description

It was reported that first surgery was done on (b)(6) 2013.Around (b)(6) 2013, dr.Noticed looseness of a screw.On (b)(6) 2014 dr.Confirmed reddening and expansion of skin.Dr.Did drainage.Pseudomonas aeruginosa was found by a culture test.On (b)(6) 2014, a nail was removed.

• Brand Name: UNKNOWN NAIL
• Type of Device: IMPLANT
• 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: 5512946
• MDR Text Key: 40733636
• Report Number: 0009610622-2016-00140
• Device Sequence Number: 1
• Product Code: JDS
• 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: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2016
• Initial Date FDA Received: 03/20/2016
• 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): Required Intervention