MAUDE Adverse Event Report: STRYKER GMBH STANDARD LAG SCREW OMEGA 100MM LENGTH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	33625100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device evaluated by mfr: device disposition unknown.
Event or Problem Description
A registrar was completing a dhs.When inserting the lag screw it appeared to become loose from the inserter.They then tried to put the plate over the lag screw and it would not go over the lag screw.A consultant was called and they came to theatre to help.They then removed the 100mm lag screw and replaced it with a 105mm lag screw.They completed the case with no adverse consequences to the patient.It added around 1 hours operating time to the procedure.The dhs lag screw was inserted using the 1 step insertion technique.

• Brand Name: STANDARD LAG SCREW OMEGA 100MM LENGTH
• 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: 8767097
• Report Number: 0008031020-2019-00780
• Device Sequence Number: 2398146
• Product Code: KTT
• UDI-Device Identifier: 07613327092875
• UDI-Public: 07613327092875
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K955306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/08/2019

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: 33625100
• Device Lot Number: B90139
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1