MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG ASNIS MICRO, CANNULATED SCREW, DIA. 3.0X20/9MM; SCREW, FIXATION, BONE

Catalog Number 40-30220

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 10/15/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Sales rep reported, surgeon placed a the k-wire, drilled first cortex but drill did not work.Took a new drill and drilling was done successfully with this new device.After drilling, depth of the hole was measured and the length of the screw verified.Screw was placed in the hole.Surgeon started removing k-wire and the screw came out as well.Surgeon repeated the whole procedure in a new position and k-wire was removed successfully and fixation completed.There was about 10 minutes delay during the operation.

Manufacturer Narrative

The reported incident that 3.0mm asnis micro, k-wire 1.2x100mm was alleged of issue s-36 (component / device stuck) could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure that components got stuck together was caused by a handling issue.The image shows that the screw has been inserted in a wrong angulation and got stuck with the k-wire.Due the deformation of the k-wire it is unlikely that the screw was inserted into the bone as reported.However, great force would be required in order to pull out an inserted screw.Poor fixation of a screw during surgery can occur due to bad bone quality or usage of an incorrect drill/screw diameter.The device inspection revealed the following: the returned cannulated screw and the k-wire were received stuck together.The k-wire is bent.The returned drill bit has been inspected and tested.The cutting performance is as intended.A review of the device history was not possible because the lot number was not communicated.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.

Event Description

Sales rep reported, surgeon placed a the k-wire, drilled first cortex but drill did not work.Took a new drill and drilling was done successfully with this new device.After drilling, depth of the hole was measured and the length of the screw verified.Screw was placed in the hole.Surgeon started removing k-wire and the screw came out as well.Surgeon repeated the whole procedure in a new position and k-wire was removed successfully and fixation completed.There was about 10 minutes delay during the operation.

• Brand Name: ASNIS MICRO, CANNULATED SCREW, DIA. 3.0X20/9MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5194561
• MDR Text Key: 30463247
• Report Number: 0008010177-2015-00284
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K071092
• 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: 10/15/2015

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: 40-30220
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 11/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 57 YR