MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE 2.3,CROSS-PIN,DENTAL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	62-23333
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.The device was missing from the kit; no device to evaluate.
Event or Problem Description
It has been reported that when opening the variax hand kit number plate tvarxm28 / ivarxm28 in the operating room, with the patient anesthetized, they noticed that the two screwdriver blades (ref: 62-17333 and 62-23333) were missing from the kit.Faced with the impossibility of placing the plate and screws, the operating surgeon was forced to synthesize the fracture using kirschner wires and sutures.

• Brand Name: SCREWDRIVER BLADE 2.3,CROSS-PIN,DENTAL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11889274
• Report Number: 0008031020-2021-00244
• Device Sequence Number: 17065113
• Product Code: LXH
• UDI-Device Identifier: 04546540541017
• UDI-Public: 04546540541017
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2021

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: 62-23333
• Device Catalogue Number: 62-23333
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1