MAUDE Adverse Event Report: STRYKER GMBH DRILL, AO, STERILE GAMMA3® Ø4,2X360 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-3642S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
It was reported that a drill bit broke during surgery.It would have been more hazardous to attempt to retrieve the remaining drill bit from the patient's bone so it was decided to be left in.
Additional Manufacturer Narrative
The reported event could be confirmed from the pictures provided and matches the alleged failure mode.A device inspection was not possible since the affected device was not returned but pictures were provided which confirms the alleged event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the type of breakage and exact root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that a drill bit broke during surgery.It would have been more hazardous to attempt to retrieve the remaining drill bit from the patient's bone so it was decided to be left in.
Event or Problem Description
It was reported that a drill bit broke during surgery.It would have been more hazardous to attempt to retrieve the remaining drill bit from the patient's bone so it was decided to be left in.
Additional Manufacturer Narrative
Please note the corrections to d9/h3, h6 method, h6 results and h6 conclusion codes.The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure mode.A device inspection revealed the following: the received drill was found to be broken from slightly above the point from where the cutting edge starts.With the available portion of the cutting edges, it could be observed that they were blunt and slightly deformed.Overall, the fracture surface shows characteristics of a brittle fracture evident by appearance of a rather smooth surface overall with few areas breaking in an uneven manner, most likely due to excessive bending load.The edges were plastically deformed indicating towards application of excessive rotational forces as well.Some thread like structures were also observed on the fracture surface which most likely have arrived from the cleaning tissues, along with observation of yellow spots which probably are dried cleaning residue.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to 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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause of the issue is attributed to a user related issue.The nature of breakage (brittle) indicates towards application of a combination of high bending and torsional load.If any further information is provided, the investigation report will be reassessed.

• Brand Name: DRILL, AO, STERILE GAMMA3® Ø4,2X360 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16972651
• Report Number: 0009610622-2023-00163
• Device Sequence Number: 2543445
• Product Code: LXH
• UDI-Device Identifier: 07613154490875
• UDI-Public: 07613154490875
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 01/09/2024

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: 1320-3642S
• Device Catalogue Number: 13203642S
• Device Lot Number: KU149392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 07/20/2023; 12/14/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 08/15/2023; 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• 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
• Patient Sex: Unknown