MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 SCREW; IMPLANT

Catalog Number UNK_KIE

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Pain (1994)

Event Date 08/13/2014

Event Type  Injury  

Manufacturer Narrative

This complaint has been reported during a literature review performed by the post market surveillance group.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.

Event Description

The manufacturer became aware of a study from (b)(6).The title of this report is ¿femoral lengthening over an intramedullary nail: a case of failed distraction¿ which was published on 13 august 2014 & associated with the ¿stryker t2 femoral nailing system¿ within that publication, post-operative complications/ adverse events were reported.It was not possible to ascertain specific device catalog or patient information 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 3 complaint was initiated retrospectively for adverse event mentioned in the report.This product inquiry addresses removal of 4 screws due to symptomatic limb-length discrepancy.The report states, ¿he had developed pain in the lower back and contralateral hip, which was exacerbated by walking and prolonged standing.Physical examination revealed a shortened left lower extremity.The gait was mildly antalgic with a slight trendelenburg component.A computed tomography (ct) scanogram demonstrated an overall leg-length discrepancy of 2.9 cm.Because of the symptomatic limb-length discrepancy, the patient elected to pursue femoral lon with a unilateral external fixator.[¿]the four screws securing the blade plate were removed by recreating the distal half of the previous incision.¿.

• Brand Name: UNKNOWN T2 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9106700
• MDR Text Key: 163214446
• Report Number: 0009610622-2019-00732
• Device Sequence Number: 1
• Product Code: HWC
• 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: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• 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: 08/29/2019
• 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
• Patient Age: 48 YR