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

Catalog Number UNK_SEL

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

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

Event Date 01/01/2000

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 ¿treatment of 2- and 3-part fractures of the proximal humerus using external fixation¿ which is associated with the stryker ¿hoffmann 2 external fixation¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from january 2000 to january 2004 and published on 26 aug 2009.It was not possible to ascertain specific device/patient 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 4 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses infection.The report states: ¿1 patient developed skin infection around the screws, but without bone engagement.The infection healed with oral antibiotic treatment.¿.

Event Description

The manufacturer became aware of a study from (b)(6) hospital, spain.The title of this report is ¿treatment of 2- and 3-part fractures of the proximal humerus using external fixation¿ which is associated with the stryker ¿hoffmann 2 external fixation¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from (b)(6) 2000 to (b)(6) 2004 and published on 26 aug 2009.It was not possible to ascertain specific device/patient 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 4 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses infection.The report states: ¿1 patient developed skin infection around the screws, but without bone engagement.The infection healed with oral antibiotic treatment.¿.

Manufacturer Narrative

New information in section h6 (patient code).

• Brand Name: UNKNOWN STEINMANN PIN
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9480980
• MDR Text Key: 187450671
• Report Number: 0008031020-2019-02283
• Device Sequence Number: 1
• Product Code: HTY
• 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: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention