MAUDE Adverse Event Report: STRYKER GMBH 5 HOLE PIN CLAMP HOFFMANN 3 Ø4/5/6MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 49222020

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 01/27/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision.On (b)(6) 2016 one hoffmann 3 ex fix was put in place (right femur & tibia).On (b)(6) 2016, the surgeon changed the position of the clamps, rods and bars.He attempted to add the 2nd side and after loosening everything, was unable to.The two pin hole clamps were removed and two new clamps were put on.

Manufacturer Narrative

The reported incident that 5 hole pin clamp hoffmann 3 ø4/5/6mm was alleged of issue s-43 (assembling issue) could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by a poor handling and reprocessing of the device.The visual inspection revealed that the device is deformed.Moreover we can see that the starry hole has a lot of scratches and marks due to usage and poor handling of the device.As the device was manufactured 4 years prior reported event, we can consider that the item has reached the end of its serviceable life.Please note that the cleaning and sterilization guide (l24002000-en rev.N_ot-rg-1_rev-2_ cleaning & sterilization guide_2015-8332) reads: ''inspection before preparing for sterilization, all medical devices should be inspected.Generally un-magnified visual inspection under good light conditions is sufficient.All parts of the devices should be checked for visible soil and/or corrosion.Note: stryker trauma & extremities typically does not specify the maximum number of uses appropriate for re-usable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.However, for certain instruments end of life has been defined, verified and specified with either a number of uses or an expiration date.However, a potential recurring situation as been identified therefore a potential nc and a capa have been raised to investigate further in order to improve our device and prevent such a failure.Product surveillance will continue to monitor complaints of this type for adverse trends.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

Revision on (b)(6) 2016 one hoffmann 3 ex fix was put in place (right femur & tibia).On (b)(6) 2016 the surgeon changed the position of the clamps, rods and bars.He attempted to add the 2nd side and after loosening everything, was unable to.The two pin hole clamps were removed and two new clamps were put on.

• Brand Name: 5 HOLE PIN CLAMP HOFFMANN 3 Ø4/5/6MM
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5458362
• MDR Text Key: 38969757
• Report Number: 0008031020-2016-00078
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: KTT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 49222020
• Device Lot Number: F18268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2014
• 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): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 84