MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN_KIE_PRODUCT; IMPLANT

Catalog Number UNK_KIE

Device Problem Failure to Osseointegrate (1863)

Patient Problem Non-union Bone Fracture (2369)

Event Date 02/12/2014

Event Type  Injury  

Event Description

It was reported that left total knee revision and supracondylar nail.Revision was due to non-union.No further information will be provided to the sales rep from the hospital.

Manufacturer Narrative

Evaluation summary: evaluation of the device could not be carried out as the device was not available (retained by hospital).A review of the dhr could not be performed as the lot code was not provided.According to the hospital the revision was due to nonunion.A more precise statement is not possible with respect to the available information.Device will not be returned.

• Brand Name: UNKNOWN_KIE_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-24 232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-24 232
• Manufacturer Contact: rose mincieli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3649511
• MDR Text Key: 20011424
• Report Number: 0009610622-2014-00103
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/12/2014

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: Health Professional
• Device Catalogue Number: UNK_KIE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2014
• Initial Date FDA Received: 02/27/2014
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 77