MAUDE Adverse Event Report: STRYKER GMBH UNKOWN APEX HALF PIN; IMPLANT

Catalog Number UNK_SEL

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Post Operative Wound Infection (2446)

Event Date 06/01/2003

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 university of (b)(6), usa which was published in july 2010.The title of this report is ¿safety and efficacy of conversion from external fixation to plate fixation in humeral shaft fractures¿ which is associated with the stryker hoffmann ii fixation system.Within that publication, postoperative complications/ adverse events were reported which occurred between june 2003 and august 2007.A review of the complaint handling database revealed that the events have not been previously reported by the hospital or by the author of the publication, therefore 2 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses pin site infection at the time of conversion to internal fixation.The study states, "at the time of conversion to plate fixation, one patient had slight erythema of the most distal pin site.This pin site was debrided and curetted to the bone during preparation for plate fixation.".

Event Description

The manufacturer became aware of a study from university of colorado, denver, usa which was published in july 2010.The title of this report is ¿safety and efficacy of conversion from external fixation to plate fixation in humeral shaft fractures¿ which is associated with the stryker hoffmann ii fixation system.Within that publication, postoperative complications/ adverse events were reported which occurred between june 2003 and august 2007.A review of the complaint handling database revealed that the events have not been previously reported by the hospital or by the author of the publication, therefore 2 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses pin site infection at the time of conversion to internal fixation.The study states, "at the time of conversion to plate fixation, one patient had slight erythema of the most distal pin site.This pin site was debrided and curetted to the bone during preparation for plate fixation.".

• Brand Name: UNKOWN APEX HALF PIN
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9387506
• MDR Text Key: 168451997
• Report Number: 0008031020-2019-01984
• Device Sequence Number: 1
• Product Code: JDW
• 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: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention