MAUDE Adverse Event Report: STRYKER GMBH DRILL, AO SMALL GAMMA3® Ø4.2X300MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13203042
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reportet: "device damaged in the surgical act.According to information on the notification form, all fragments were recovered.".
Additional Manufacturer Narrative
Please note corrections to d4 lot# and h6 component code.The reported event could be confirmed since the device was returned and matches the alleged failure.The received drill, ao small gamma3 is broken off from the distal end and the tip was not returned for verification purposes.The cutting flutes are deformed from the sides indicating the signs of usage.The breakage surface indicates breakage in a brittle manner as the surface is relatively smooth and has very little deformation around the area.The breakage occurred due to application of a high bending load, leading to a forced brittle fracture.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with the values in the material specification.Due to the fact that this device was manufactured in 2012, and has more than 10 years of compliant performance, a material analysis was not deemed necessary, since if there were any material related issues, it would have been evident in the beginning of life of the device.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to being user related.The appearance of a breakage surface indicates towards application of a high bending load, leading to a forced brittle fracture.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "device damaged in the surgical act.According to information on the notification form, all fragments were recovered.".

• Brand Name: DRILL, AO SMALL GAMMA3® Ø4.2X300MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17777822
• Report Number: 0009610622-2023-00329
• Device Sequence Number: 17826678
• Product Code: LXH
• UDI-Device Identifier: 04546540377883
• UDI-Public: 04546540377883
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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: 13203042
• Device Lot Number: KBU29026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male