MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN HOFFMANN EXTERNAL FIXATOR; IMPLANT

Catalog Number UNK_SEL

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/1998

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 ¿wrist-bridging versus non-bridging external fixation for displaced distal radius fractures.¿ which is associated with the stryker hoffman external fixation system.Within that publication, post-operative complications/ adverse events were reported from march 1998 to march 2002.It was not possible to ascertain specific device and 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 19 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses revision due to fracture displacement.The report states: ¿a patient (wrist bridging) whose radiographic examination 8 days postoperatively was judged by a surgeon (not involved in the trial) as fracture displacement, underwent a second closed reduction and addition of a percutaneous pin.¿.

Manufacturer Narrative

New information in section h6 (patient code), correction in section h6 (device code).

Event Description

The manufacturer became aware of a study from hässleholm hospital, (b)(6) sweden.The title of this report is ¿wrist-bridging versus non-bridging external fixation for displaced distal radius fractures.¿ which is associated with the stryker hoffman external fixation system.Within that publication, post-operative complications/ adverse events were reported from march 1998 to march 2002.It was not possible to ascertain specific device and 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 19 complaint were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses revision due to fracture displacement.The report states: ¿a patient (wrist bridging) whose radiographic examination 8 days postoperatively was judged by a surgeon (not involved in the trial) as fracture displacement, underwent a second closed reduction and addition of a percutaneous pin.¿.

• Brand Name: UNKNOWN HOFFMANN EXTERNAL FIXATOR
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9478009
• MDR Text Key: 185545773
• Report Number: 0008031020-2019-02256
• 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: 02/11/2020

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: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention