MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN_KIE_PRODUCT; IMPLANT

Catalog Number UNK_KIE

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The manufacturer became aware of a 'retrospective data collection report' from (b)(6).The title of this study is ¿a retrospective data collection of the treatment of humeral fractures with the t2 proximal humeral nailing system (phn)¿ and is associated with the t2 proximal humeral nailing system (phn).Within that publication, post-operative complications/ adverse events were reported, which occurred between 2012 to 2017.It was not possible to ascertain specific device catalogs from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 30 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses implant (nail) dislocation.The report states, "a (b)(6) caucasian male suffered from a proximal humeral fracture and was treated with t2 phn.One month after surgery the screws were found to be loosened and the nail was dislocated.A revision surgery was performed the nail was removed and osteosynthesis with philos plate performed.After a few days a revision surgery had to be performed to correct the position of philos plate.One year after insertion of the plate, it was found to be dislocated and was removed.The fracture consolidated in incorrect alignment, the outcome of motoric function is not documented (#65).".

• Brand Name: UNKNOWN_KIE_PRODUCT
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8225691
• MDR Text Key: 132338554
• Report Number: 0009610622-2019-00025
• 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: 01/08/2019

1 Device 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: 12/17/2018
• Initial Date FDA Received: 01/08/2019
• 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