MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN MONOTUBE UNILATERAL FIXATOR; IMPLANT

Catalog Number UNK_SEL

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Deformity/ Disfigurement (2360); No Code Available (3191)

Event Date 01/01/1992

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) hospital, (b)(6) which was published in july-2003.The title of this report is ¿technique and considerations when using external fixation as a standard treatment of femoral fractures in children¿ which is associated with the stryker unilateral fixator and apex pin system.Within that publication, postoperative complications/ adverse events were reported which occurred between 1992 and 2000.It was not possible to ascertain specific device or patient details from the study, 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 46 complaint was initiated retrospectively for adverse event mentioned in the study.This product inquiry addresses residual procurvatum >15° after 1 year.6 out of 7 cases.

Event Description

The manufacturer became aware of a study from (b)(6) hospital, sweden which was published in (b)(6) 2003.The title of this report is ¿technique and considerations when using external fixation as a standard treatment of femoral fractures in children¿ which is associated with the stryker unilateral fixator and apex pin system.Within that publication, postoperative complications/ adverse events were reported which occurred between 1992 and 2000.It was not possible to ascertain specific device or patient details from the study, 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 46 complaint was initiated retrospectively for adverse event mentioned in the study.This product inquiry addresses residual procurvatum >15° after 1 year.6 out of 7 cases.

Manufacturer Narrative

New information in section h6 (device code and patient code).

• Brand Name: UNKNOWN MONOTUBE UNILATERAL FIXATOR
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9380391
• MDR Text Key: 185208883
• Report Number: 0008031020-2019-01906
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other