MAUDE Adverse Event Report: STRYKER GMBH CONNECTING BOLT OMEGA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	704004
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.
Event or Problem Description
Picked instruments up from hospital.They were used in a case where stryker omega implants were removed.Replacement implants were used, but from another company.No rep was present, but all implants removed successfully.T handle and lag screw inserter stuck together.Connecting bolt threads broken.
Event or Problem Description
Picked instruments up from hospital.They were used in a case where stryker omega implants were removed.Replacement implants were used, but from another company.No rep was present, but all implants removed successfully.T handle and lag screw inserter stuck together.Connecting bolt threads broken.
Additional Manufacturer Narrative
The reported event that connecting bolt omega was alleged of 'instrument breakage identified out of surgery' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided despite multiple attempts.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 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.

• Brand Name: CONNECTING BOLT OMEGA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7924067
• Report Number: 0008031020-2018-00697
• Device Sequence Number: 13952772
• Product Code: LXH
• UDI-Device Identifier: 07613153054436
• UDI-Public: 07613153054436
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2018

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: 704004
• Device Lot Number: W34148
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 12/01/2018
• 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