MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT, AO DIA2.0MM X 135MM, SCALED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	703690
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "'the tip of the drill bit breaks off during the drilling process.The tip cannot be retrieved and remains in there.It cannot be ruled out that this could lead to harm to the patient in the future.''.
Event or Problem Description
As reported: "'the tip of the drill bit breaks off during the drilling process.The tip cannot be retrieved and remains in there.It cannot be ruled out that this could lead to harm to the patient in the future.''.
Additional Manufacturer Narrative
Correction: please refer to section a2 (age at time of event).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.Broken surface of the drill appears relatively smooth without showing any plastic deformation signs which indicates towards a brittle failure of the drill due to mechanical overload leading to sudden breakage.Edges of the drill are slightly deformed and worn out which indicates towards the significant usage of the device.The outer diameter of the drill was found within specification.Furthermore, a hardness test according to (b)(6) 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 a mechanical overload while usage of the drill.Wear marks and deformation indicates that the device was already blunt prior to surgery and a worn-out instrument is more prone to breakage.The hcp might have failed to inspect the instrument properly prior to use, as stated in the ifu.In the provided surgery report, the incident of the drill breakage is mentioned but there is no useful information available to comment upon the further possibilities of failure, other records like x-rays and ct scans could be beneficial to add more observations in the investigation but unfortunately these records are missing.If any additional information is provided, the investigation will be reassessed.
Additional Manufacturer Narrative
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.Broken surface of the drill appears relatively smooth without showing any plastic deformation signs which indicates towards a brittle failure of the drill due to mechanical overload leading to sudden breakage.Edges of the drill are slightly deformed and worn out which indicates towards the significant usage of the device.The outer diameter of the drill was found within specification.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.Opinion from the hcp on received x-ray images: "with the provided images it is not easy to see the full trajectory of the drill.I cannot confirm the contact of drill with the already placed screw, it is a potential cause of breakage, you would assume though the hcp would have noticed hitting/ touching the screw if that was already in place.Potential causes: a dull drill (which should have been discarded prior to surgery), if it was not a single use drill; hard bone; bending of the drill during drilling" based on the investigation, the root cause was attributed to be user related.The event was caused by a mechanical overload while usage of the drill.Wear marks and deformation indicates that the device was already blunt prior to surgery and a worn out instrument is more prone to breakage.The hcp might have failed to inspect the instrument properly prior to use, as stated in the ifu.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "'the tip of the drill bit breaks off during the drilling process.The tip cannot be retrieved and remains in there.It cannot be ruled out that this could lead to harm to the patient in the future.''.

• Brand Name: DRILL BIT, AO DIA2.0MM X 135MM, SCALED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20836495
• Report Number: 0008031020-2024-00634
• Device Sequence Number: 18325492
• Product Code: LXH
• UDI-Device Identifier: 07613327069853
• UDI-Public: (01)07613327069853(10)6000075783
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2025

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: 703690
• Device Lot Number: AJ08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 01/22/2025; 08/05/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 02/18/2025; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2018
• 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: Other
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 50 KG