MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH UNKNOWN_TRAUMA_AND_EXTREMITY_PRODUCT; IMPLANT

Catalog Number UNK_TNE

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 11/18/2014

Event Type  malfunction  

Event Description

During asnis3 extract surgery, the surgeon used the screw driver.When the surgeon rotated the screw driver, the hex part of screw head deformed.Therefore the surgeon used the extractor.When the extractor was inserted in screw, the tip of extractor and the screw head broke.The surgeon used the chisel and extracted the screw shaft.The removed screw was discarded in the hospital.

Manufacturer Narrative

Device was discarded by the hospital.No evaluation will be performed.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

Evaluation summary: the reported event that the screwhead broke could not be confirmed, since the device was not returned for evaluation.The root cause of the reported event could not be determined as the reported device was not returned for evaluation.The following root causes were evaluated as possible (not exhaustive): - bone in- and/or overgrowth - implant stays longer in patient as intended - pre damaged/bent implant - implanted in an unintended patient population a review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.If any further information is provided, the investigation report will be updated.

Event Description

During asnis3 extract surgery, the surgeon used the screw driver.When the surgeon rotated the screw driver, the hex part of screw head deformed.Therefore the surgeon used the extractor.When the extractor was inserted in screw, the tip of extractor and the screw head broke.The surgeon used the chisel and extracted the screw shaft.The removed screw was discarded in the hospital.

• Brand Name: UNKNOWN_TRAUMA_AND_EXTREMITY_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4327040
• MDR Text Key: 5255246
• Report Number: 0008031020-2014-00604
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/18/2014

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: UNK_TNE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 12/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 30 YR