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 Code	Perforation (2001)
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.
Additional Manufacturer Narrative
The reported event could be confirmed, since the returned drill bit is out of specification.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 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 am10/bb has a diameter of 2.59mm, while the specification requires a diameter of 2.00mm 0/-0.02.Based on that it can be concluded that this drill bit is out of specification as complained.Based on investigation, the root cause was attributed to a manufacturing related issue.One step during the manufacturing process was not carried out properly and that the returned 2.6mm drill bit was marked with a incorrect catalog number.An non-conformity report was opened at the manufacturing site to address this event.
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".

• 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: 16402737
• Report Number: 0008031020-2023-00091
• Device Sequence Number: 19674202
• 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
• Report Date (Section B): 05/02/2023

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: AM10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2022
• 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