MAUDE Adverse Event Report: STRYKER GMBH 10 HOLE PIN CLAMP HOFFMANN II MRI 4-6MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 49212060

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2016

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It is reported by the nurse that the approach rod does not fit in the jaw on the green side.Replacement was available.

Manufacturer Narrative

The reported incident that 10 hole pin clamp hoffmann ii mri 4-6mm was alleged of issue s-31 (no fitting) could be confirmed, since the returned device matched the reported failure.Based on investigation, the root cause was attributed to a user related issue.The failure was probably caused by mishandling of the device.The device inspection revealed that the sample post cannot be inserted in one of the holes in the green side of the pin clamp, confirming the reported event.This hole is deformed inside, which points to the multiple usage of this device.These deformations are what is stopping the post to be fully inserted in the pin clamp.Multiple use devices need to be carefully inspected prior and post surgery, since damages can have occurred in the last usage and so screening is needed not to reuse damaged parts.Also note, that this clamp should not be tightened without the post inserted, otherwise deformation can occur that can compromise the performance of the device.Note, as stated in the operative technique (lh2mri-ot rev 1 hoffmann ii mri optech): ''note: do not over torque the bolt b which does not contain a post.'' [original statement(s)].Note, as stated in the ifu (v15034): ''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.'' [original statement(s)].A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

Event Description

It is reported by the nurse that the approach rod does not fit in the jaw on the green side.Replacement was available.

• Brand Name: 10 HOLE PIN CLAMP HOFFMANN II MRI 4-6MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5493912
• MDR Text Key: 40325836
• Report Number: 0008031020-2016-00118
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• PMA/PMN Number: K051306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/12/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 49212060
• Device Lot Number: R16484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 03/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other