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	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The hospital reported the following event: "the operating theater of our hospital declared a materiovigilance incident when using cervical omega ii screws 100 mm st, ref 33625100, lot y02502 and l09620.Description of the facts: the 2 omega 100 mm dhs screws broke at the threaded pitch during installation.The materiovigilance number to be recalled for all correspondence is (b)(4)." longer intervention.Actions taken to complete the intervention: screw change (of the screw diameter).
Event or Problem Description
The hospital reported the following event : " the operating theater of our hospital declared a materiovigilance incident when using cervical omega ii screws 100 mm st, ref 33625100, lot y02502 and l09620.Description of the facts: the 2 omega 100 mm dhs screws broke at the threaded pitch during installation.The materiovigilance number to be recalled for all correspondence is 2018-a084" longer intervention.Actions taken to complete the intervention: screw change (of the screw diameter).
Additional Manufacturer Narrative
The reported event that standard lag screw omega 100mm length was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by inadequate use.Unfortunately no further details could be obtained in order to clearly identify the encountered problems.The device inspection revealed the following.The pegs on both coupling parts are indeed completely missing / broken off (cut off?).Note that we have not had any similar complaints with lag screws which had been so severely damaged like these two (both in the same manner).This leads us to believe that the user did encounter some difficulties.We are certain that the surgeon did not follow the op instruction or manipulated / damaged these two lag screws in an unexplainable way.Plier marks are also visible.Note that no power tool should be used for the lag screw insertion.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.

• 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: 8084077
• Report Number: 0009610622-2018-01407
• Device Sequence Number: 13931993
• Product Code: KTT
• UDI-Device Identifier: 07613327092875
• UDI-Public: 07613327092875
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2019

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 Expiration Date: 05/31/2023
• Device Catalogue Number: 33625100
• Device Lot Number: Y02502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other