MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO T2 HUMERUS 3,5X230 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	1806-3540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "t2 humerus, right, orif.At the time of distal lateral fixation, it was opened with a radiolucent drill and measured with a depth gauge, but it did not reach the cortical bone on the other side.When re-drilling, the usual drill (1806-3540) was used, but it was broken after penetrating the cortical bone on the opposite side.The broken drill tip was about 5 to 10 mm from the cortical bone on the front side, and could be removed with pliers.After that, the usual procedure was performed and the operation was completed.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the received drill shows signs of intense usage.The drill was found to be broken from the shaft region.The cutting edges of the tip portion are absolutely blunt and severe material deformation can also be seen around it.The cutting edges of the shaft portion, although normal, had minor damaged cutting edges.The breakage surface reveals a relatively smoother surface at the centre.This confirms a brittle fracture followed by abrupt breakage towards one of the edges.Plastic deformation of edges is there but very minimal.All these signs are evident enough to suggest that there was an intense and abnormal usage of the drill including high torsional and bending load which lead to a forced fracture.The critical diameter of the drill (flute area) was observed to be 4.44mm as required against a range of 4.40mm 4.50mm.Similarly, the average hardness of the drill was observed to be 52.5 hrc as required against a range of 52.0 hrc 56.0 hrc.As per the dimensional inspection and hardness testing, the returned drill was found to be within specifications.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.Based on the investigation the root cause was attributed to a user related issue.The breakage of the drill happened due to a combined torsional and bending overload, evident by the brittle nature of the breakage, applied in order to appreciate the drill through the medial cortex.Moreover, it was observed that the remaining cutting edges of the drill tip returned are significantly worn and covered with dents; the drill is not sharp anymore.A review of the labeling did not indicate any abnormalities.The ifu instructs the user that: ¿ensure that the drilling and cutting tools to be used are sharp; discard them if they are not.¿ if any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "t2 humerus, right, orif.At the time of distal lateral fixation, it was opened with a radiolucent drill and measured with a depth gauge, but it did not reach the cortical bone on the other side.When re-drilling, the usual drill (1806-3540) was used, but it was broken after penetrating the cortical bone on the opposite side.The broken drill tip was about 5 to 10 mm from the cortical bone on the front side, and could be removed with pliers.After that, the usual procedure was performed and the operation was completed.".

• Brand Name: DRILL, AO T2 HUMERUS 3,5X230 MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 10218481
• Report Number: 0009610622-2020-00310
• Device Sequence Number: 2552384
• Product Code: HWE
• UDI-Device Identifier: 04546540196606
• UDI-Public: 04546540196606
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2020

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: 1806-3540
• Device Catalogue Number: 18063540
• Device Lot Number: K127681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR