MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN PROXIMAL LOCKING SCREW; IMPLANT

Catalog Number UNK_KIE

Device Problem Device Slipped (1584)

Patient Problem Pain (1994)

Event Date 05/01/2014

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device evaluated by mfr: device disposition unknown.

Event Description

The manufacturer became aware of a study from department of trauma & orthopaedics, altnagelvin hospital, northern ireland, uk.The title of this study is ¿pre-requisites for optimum centering of a tibiotalocalcaneal arthrodesis nail¿ and is associated with the t2 ankle arthrodesis nail.The study published in may 2014 reported post-operative complications/ adverse events.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, 9 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses locking screws backed out.2 out of 2 cases.The study states: "patient required removal of both proximal tibial locking screws and the postero-anterior calcaneal screw for ongoing pain at these sites, despite the screw heads not being palpable.¿.

• Brand Name: UNKNOWN PROXIMAL LOCKING SCREW
• 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: 8524017
• MDR Text Key: 142256015
• Report Number: 0009610622-2019-00200
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• 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
• Date Manufacturer Received: 04/01/2019
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention