MAUDE Adverse Event Report: STRYKER GMBH LAG SCREW ADAPTER OMEGA 3; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	704009
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device cannot be decontaminated.
Event or Problem Description
"the customer reported that the lag screw adapter broke while the surgeon was inserting the screw.The lag screw had to be removed and a new screw was inserted." update: the case was completed by opening another set.

• Brand Name: LAG SCREW ADAPTER OMEGA 3
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11414010
• Report Number: 0008031020-2021-00079
• Device Sequence Number: 4041936
• Product Code: LXH
• UDI-Device Identifier: 07613153054511
• UDI-Public: 07613153054511
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2021

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 Model Number: 704009
• Device Catalogue Number: 704009
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1