MAUDE Adverse Event Report: STRYKER GMBH TWIST DRILL, DIAM.2.5X94MM, WL 59MM, STRYKER SHAFT END; BIT, DRILL

Model Number 60-19326

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Date 10/14/2022

Event Type  Injury  

Event Description

It was reported that "too fast threaded drill (second device), for which the surgeon pierced the finger of the patient.Injuries requiring healing care.".

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Manufacturer Narrative

Correction - please refer d4 catalog#, gtin.The reported event could not be confirmed although the device was returned for evaluation since no evidence for the adverse impact to the patient was provided.The device inspection revealed the following: the visual inspection has shown that the received twist drill bit is in a very used condition, the laser markings are partially faded.The color coding is faded and partially missing.The shaft between the color coding and the cutting flutes is strongly worn.There are chatter marks, caused by many contacts between the shaft and the drill sleeve all over the shaft visible.The cutting edges at the flutes are worn, there are nicks and wear marks all over.Also the cutting edge at the forefront are blunt, the edges rounded and compressed in the outer area.A review of the device history for the reported lot did not indicate any abnormalities.The lot in question was released in june 2006 and we are not aware of any other complaint of this nature for the catalog#: 60-25126 or 60-25126s.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 investigation, the root cause was attributed to a user related issue.The investigation has shown that the drill bit was obviously many times used since it was manufactured.The failure was finally caused by the use of a blunt drill bit, by that higher force than normal was required to drill through the bone and therefore it was not possible to stop the drill after the bone was perforated.In relation to this complaint following statements of the variax instruments instructions for use can be pointed out: "warning twist drills are for single use only." if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that "too fast threaded drill (second device), for which the surgeon pierced the finger of the patient.Injuries requiring healing care.".

• Brand Name: TWIST DRILL, DIAM.2.5X94MM, WL 59MM, STRYKER SHAFT END
• Type of Device: BIT, DRILL
• 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: 15840698
• MDR Text Key: 304091815
• Report Number: 0008031020-2022-00637
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 04546540247360
• UDI-Public: 04546540247360
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60-19326
• Device Catalogue Number: 60-25126
• Device Lot Number: W05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other