MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN APEX PIN; IMPLANT

Catalog Number UNK_SEL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); No Code Available (3191)

Event Date 10/01/2008

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).The title of this report is ¿external fixation and pseudoaneurysm: report of a case related to tibial lengthening¿ which is associated with the stryker ¿hoffman external fixation¿ system.Within that publication, post-operative complication/ adverse event was reported which was published on 1- october-2008.It was not possible to ascertain specific device details 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 2 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses application of skin graft to the wound.The report states: ¿a (b)(6)-year-old male drug addict was admitted to our hospital after a motorcycle accident.He had sustained an open fracture of the lower third of his left tibia, gustillo type iiib.The initial treatment was debridement and stabilization with a hoffmann ii external fixator (stryker, (b)(4)).Seven days later the wound was covered with a skin graft.One month later the patient developed fever, inflammation, and pyorrhea due to osteomyelitis.Resection of the infected peripheral segment of the tibia and ankle fusion were performed using an orthofix monolateral external fixation [non-stryker device].¿.

Event Description

The manufacturer became aware of a study from hellenic red cross hospital, athens, greece.The title of this report is ¿external fixation and pseudoaneurysm: report of a case related to tibial lengthening¿ which is associated with the stryker ¿hoffman external fixation¿ system.Within that publication, post-operative complication/ adverse event was reported which was published on 1- october-2008.It was not possible to ascertain specific device details 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 2 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses application of skin graft to the wound.The report states: ¿a 33-year-old male drug addict was admitted to our hospital after a motorcycle accident.He had sustained an open fracture of the lower third of his left tibia, gustillo type iiib.The initial treatment was debridement and stabilization with a hoffmann ii external fixator (stryker, (b)(6), new jersey).Seven days later the wound was covered with a skin graft.One month later the patient developed fever, inflammation, and pyorrhea due to osteomyelitis.Resection of the infected peripheral segment of the tibia and ankle fusion were performed using an orthofix monolateral external fixation [non-stryker device].¿.

Manufacturer Narrative

Additional information added in section h6 (patient and device code).

• Brand Name: UNKNOWN APEX PIN
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9304372
• MDR Text Key: 178645371
• Report Number: 0008031020-2019-01603
• 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: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• 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: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR