MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT SPS Ø2.5X180MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	700351
Medical Device Problem Codes	Difficult to Remove (1528); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
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: "difficult to remove drill.Abnormal noise.Presumably noticed after surgery.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and is fully functional.The device inspection revealed the following: the cutting edges of the drill bill are blunt and slightly damaged.This indicates that the drill bit was intensely used.Usage marks can be seen on the proximal, insertion tip of the drill bit.In addition to intensive usage, these marks could indicate that the insertion or the disassembling of the drill bit was forced during usage and was not done as intended.During the functional inspection, the drill bit was tested with a sps ao coupling handle.The drill bit could be inserted and disassembled from the handle without any issue.Therefore, this device could be considered as fully functional.Based on the investigation, the root cause was attributed to an user related issue.The drill bit may not have been inserted or disassembled as intended.It has to be taken into account that the coupling handle or the power tool used with the drill bit was not returned.Therefore, it is not possible to know if the reported failure was caused by one of these devices and not by the drill bit itself.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.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "difficult to remove drill.Abnormal noise.Presumably noticed after surgery.".

• Brand Name: DRILL BIT SPS Ø2.5X180MM AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14219268
• Report Number: 0008031020-2022-00211
• Device Sequence Number: 14779634
• Product Code: LXH
• UDI-Device Identifier: 04546540413758
• UDI-Public: 04546540413758
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 700351
• Device Catalogue Number: 700351
• Device Lot Number: 03857L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2017
• 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
• Patient Sex: Unknown