MAUDE Adverse Event Report: STRYKER GMBH DRILL, AO T2 Ø3,5X230 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	18063540
Medical Device Problem Codes	Break (1069); Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "during t2h surgery, screws were inserted to the distal holes of the nail and the fracture was crimped with a back strike.The drill then did not pass through the oblique hole of the nail during fixation of the proximal holes.After changing to screw insertion into the transverse holes, the drill did not pass through, so the connection between the device and the nail was retightened with a wrench, but the situation did not change.The screw hole was widened in order starting with the thinner k-wire and finally the drill was passed into the hole, the tip of the drill broke off in the hole, and it was left in place.Furthermore, the device connections of the nail was observed to extend outward over the entire circumference.Finally, one screw was inserted in the proximal oblique hole, and the surgery was completed by tightening the end cap".
Event or Problem Description
As reported: "during t2h surgery, screws were inserted to the distal holes of the nail and the fracture was crimped with a back strike.The drill then did not pass through the oblique hole of the nail during fixation of the proximal holes.After changing to screw insertion into the transverse holes, the drill did not pass through, so the connection between the device and the nail was retightened with a wrench, but the situation did not change.The screw hole was widened in order starting with the thinner k-wire and finally the drill was passed into the hole, the tip of the drill broke off in the hole, and it was left in place.Furthermore, the device connections of the nail was observed to extend outward over the entire circumference.Finally, one screw was inserted in the proximal oblique hole, and the surgery was completed by tightening the end cap".
Additional Manufacturer Narrative
Correction please refer to d4 lot number.The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The received drill is broken from the tip and the broken fragment was not returned.Also, the cutting edges at the flutes are damaged.There are many nicks visible, most likely caused by metallic contacts with the nail over the years as the device was manufactured in the year 2019.The microscopic inspection of the fracture face shows the characteristics of a typical brittle overload fracture as indicated by the smooth uniform surface with some visible chevron lines.Relevant dimensions were measured and found within specifications.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with the values in the material specification.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on the investigation, the root cause was attributed to be user related.The event was caused by the application of excess torsional and bending forces while drilling into a hard bone with a slightly blunt and damaged drill.In this relation following statement of the t2 instruments instructions for use can be pointed out ¿ensure that the drilling and cutting tools to be used are sharp, discard them if they are not.¿ excerpts from the clinical assessment in a similar case ¿an intra-operative breakage of a drill is a rare but common complication and well known to an experienced user.It is caused by twisting the drill and too much bending.Breakage caused by material defect is very rare in current manufacturing technology.It is of interest whether a broken part of a drill can be left in the bone or should be retrieved, also in the case that greater harm to the bone would be done.It is well known to an expert user that a broken part of a drill which is completely embedded in the bone normally does not cause any harm.In absence of a nickel allergy, the material used for the drill does not cause any local or systemic incompatibility.Therefore, no further surgical procedures in this special case are required." however, it lies in the responsibility of the treating surgeon to leave or to remove the broken off part.Further, as requested by the sales rep, raw material certificate of the failed drill was traced using the lot number which shows that the drill is not having nickel.The material used is stainless steel 440b 1.4112 which contains carbon, phosphorus, silicon, sulphur, manganese, chromium, molybdenum, vanadium and iron.If any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL, AO T2 Ø3,5X230 MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21390096
• Report Number: 0008031020-2025-00296
• Device Sequence Number: 20901374
• Product Code: HWE
• UDI-Device Identifier: 04546540196606
• UDI-Public: (01)04546540196606(11)190418(10)K042617
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 05/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 18063540
• Device Lot Number: KU109235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR
• Patient Sex: Male