MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SCREWDRIVER SHAFT, COMPRESSION T2 HUMERUS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0263
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned since it was discarded according to information received.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported, during the operation, when trying to apply compression, the welded part of the driver was damaged.The sr explained to the surgeon about the possibility of damage before applying compression.The surgeon used the screwdriver for compression screw after consent.After all, the welded part was easily damaged.Since there are two drivers installed in the instrument, another driver was used.The welded part was also easily damaged.The surgeon was stated that he wanted more compression, but because there was no longer a driver tip, he had to bend the damaged driver 90 degrees with pliers and used it to put more pressure.Pressure was applied until the surgeon was satisfied, and the operation ended safely.

• Brand Name: SCREWDRIVER SHAFT, COMPRESSION T2 HUMERUS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 10150706
• Report Number: 0009610622-2020-00289
• Device Sequence Number: 19374034
• Product Code: LXH
• UDI-Device Identifier: 04546540196330
• UDI-Public: 04546540196330
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2020

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: 1806-0263
• Device Catalogue Number: 18060263
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1