MAUDE Adverse Event Report: STRYKER GMBH STANDARD LAG SCREW OMEGA 105MM LENGTH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 33625105

Device Problem Material Fragmentation (1261)

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

Event Date 10/12/2017

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Product disposition unknown.

Event Description

The customer reported that the end of the omega lag screw sheared off during the case as the registrar turned the handle during insertion.Two shards of metal broke off and were retrieved from the patient.There was a surgical delay of 10 minutes.The case was completed and the consultant was happy that the lag screw had already been seated far enough in.

Manufacturer Narrative

The reported event that standard lag screw omega 105mm length was alleged of 'breakage during surgery' could not be confirmed, as case was completed and lag screw had been implanted.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A deformation of the lag screw can occur if; either the lag screw had not been properly assembled with the lag screw adapter or just inadequate use (over tightening) has resulted in such described deformations.The operative technique (omg-st-2 en omega3 compression hip screw optech) was reviewed and found to be complete.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

The customer reported that the end of the omega lag screw sheared off during the case as the registrar turned the handle during insertion.Two shards of metal broke off and were retrieved from the patient.There was a surgical delay of 10 minutes.The case was completed and the consultant was happy that the lag screw had already been seated far enough in.

• Brand Name: STANDARD LAG SCREW OMEGA 105MM LENGTH
• 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: 6994386
• MDR Text Key: 91917674
• Report Number: 0008031020-2017-00641
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 33625105
• Device Lot Number: L09623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 89 YR