MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT, AO DIA2.0MM X 135MM, SCALED; PLATE, FIXATION, BONE

Model Number	703690S
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Inaccurate Information (4051)
Health Effect - Clinical Codes	Perforation (2001); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "a packet marked as 2.0 drill and colour coded as such wasn't a 2.0 drill.Caused slight harm to wrist of the patient when drilling the screws on shafts of radius plate and holes too large for screws.When re-drilling an adjacent hole the plate could be put back on but at a less optimal position.Checked alongside another 2.0 drill from different packet and was very different".
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: "a packet marked as 2.0 drill and colour coded as such wasn't a 2.0 drill.Caused slight harm to wrist of the patient when drilling the screws on shafts of radius plate and holes too large for screws.When re-drilling an adjacent hole the plate could be put back on but at a less optimal position.Checked alongside another 2.0 drill from different packet and was very different".
Additional Manufacturer Narrative
The reported event could not be confirmed since the returned device is conforming to specifications the device inspection revealed the following: two drill bits, laser marked with catalog number 703690, were returned for evaluation.The visual inspection does confirm a difference in the dimensions, the drill bit with the lot am10/bb (captured under complaint #(b)(4)) is thicker and longer that the drill bit with lot am11/bb.The dimensional inspection with a caliper has shown the drill bit with lot am11/bb has a diameter of 1.99mm, which is within the specification of 2.00mm 0/-0.02.Based on that it can be concluded that this drill bit is within the specification and that this drill bit was only returned for comparison with the incorrect one.This comparison is also mentioned in the event description and the description only speaks of a single drill that is not correct.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.No product related issue could be detected, based on the available information and the investigation findings was the device returned as a concomitant device for comparison with the incorrect drill bit.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "a packet marked as 2.0 drill and colour coded as such wasn't a 2.0 drill.Caused slight harm to wrist of the patient when drilling the screws on shafts of radius plate and holes too large for screws.When re-drilling an adjacent hole the plate could be put back on but at a less optimal position.Checked alongside another 2.0 drill from different packet and was very different".
Additional Manufacturer Narrative
Please note corrections to codes h6.Based on additional information received, it was concluded that there was no allegation against the subject device.The returned device, intended for use as a comparison drill, was inadvertently reported as an mdr.Please disregard manufacturer report number 0008031020-2023-00116.

• Brand Name: DRILL BIT, AO DIA2.0MM X 135MM, SCALED
• Common Device Name: PLATE, FIXATION, BONE
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16591685
• Report Number: 0008031020-2023-00116
• Device Sequence Number: 20067950
• Product Code: HRS
• UDI-Device Identifier: 07613327071764
• UDI-Public: 07613327071764
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170727
• 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): 05/17/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 703690S
• Device Catalogue Number: 703690S
• Device Lot Number: AM11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 04/06/2023; 05/17/2024
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/03/2023; 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown