MAUDE Adverse Event Report: STRYKER GMBH TUBE TO ROD COUPLING HOFFMANN II COMPACT MRI 15MM/5MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	49411100
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
An (b)(6) boy was operated with a crooked and shortened right upper arm.A correction osteotomy and placement of a distraction fixator was planned.For this the hospital ordered an extra distractor rod and 2 fixation clamps for the hoffamnn compact fixateur.During the operation, it turned out that one of the clamps was difficult to open and operate, the second was not functional.Multiple attempts to loosen the clamp so that it could be opened or closed were frustrating.Finally, after a previous osteotomy, a conventional connecting rod had to be attached.As a result, the boy must get the planned distractor after 1 week in a new anesthetic.It is to be hoped that there will be no change of position within the scope of the manipulation or that the callus will not break off.This could jeopardize the overall outcome of the operation.Revision is planned for (b)(6) 2019.Surgical delay of 60 minutes.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device is fully functional.The failure event reported cannot be confirmed as the visual and functional inspection showed that the device is fully functional, the tightening and untightening of the pin was made using a pin driver: the manipulation of the pin wasn't difficult.The instructions for use remind that the user should be familiar with the use of the devices: "ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the external fixation devices, which are described in the operative technique manual for the product system.As a conclusion, this case is thus classified as a user related issue.
Event or Problem Description
An 8-year-old boy was operated with a crooked and shortened right upper arm.A correction osteotomy and placement of a distraction fixator was planned.For this the hospital ordered an extra distractor rod and 2 fixation clamps for the hoffamnn compact fixateur.During the operation, it turned out that one of the clamps was difficult to open and operate, the second was not functional.Multiple attempts to loosen the clamp so that it could be opened or closed were frustrating.Finally, after a previous osteotomy, a conventional connecting rod had to be attached.As a result, the boy must get the planned distractor after 1 week in a new anesthetic.It is to be hoped that there will be no change of position within the scope of the manipulation or that the callus will not break off.This could jeopardize the overall outcome of the operation.Revision is planned for (b)(6) 2019.Surgical delay of 60 minutes.

• Brand Name: TUBE TO ROD COUPLING HOFFMANN II COMPACT MRI 15MM/5MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8457271
• Report Number: 0008031020-2019-00329
• Device Sequence Number: 2887521
• Product Code: KTT
• UDI-Device Identifier: 04546540492722
• UDI-Public: 04546540492722
• Combination Product (Y/N): N
• PMA/510(K) Number: K053038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 49411100
• Device Lot Number: Y28479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 8 YR