MAUDE Adverse Event Report: STRYKER GMBH DRILL SLEEVE LOCKING AXSOSTI, 4.3MM DRILL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	703792
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device returned to circulation at the hospital after cleaning.
Event or Problem Description
As reported: "we were using an axsos3 distal femur plate for a periprosthetic fracture using the consigned targeting instrument set.The plate was inserted into the patient roughly 20-30 minutes after the first incision, attached to the targeting instruments.As the surgeon/registrar attempted to insert the first locking screw distally using a tissue sleeve and locking drill sleeve, they noticed that the sleeve was contaminated with what was believed to be blood from a previous case after pushing the locking drill bit through the drill sleeve and pulling it back out (they hadn¿t drilled into the patient at this stage).They decided to push ahead with the case, they put the contaminated drill sleeve and drill bit to the side and carried on using the rest of the clean instruments.".
Event or Problem Description
As reported: "we were using an axsos3 distal femur plate for a periprosthetic fracture using the consigned targeting instrument set.The plate was inserted into the patient roughly 20-30 minutes after the first incision, attached to the targeting instruments.As the surgeon/registrar attempted to insert the first locking screw distally using a tissue sleeve and locking drill sleeve, they noticed that the sleeve was contaminated with what was believed to be blood from a previous case after pushing the locking drill bit through the drill sleeve and pulling it back out (they hadn¿t drilled into the patient at this stage).They decided to push ahead with the case, they put the contaminated drill sleeve and drill bit to the side and carried on using the rest of the clean instruments.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Based on the provided information, the root cause was attributed to a user related issue.The failure was caused by inappropriate cleaning and inspection during reprocessing of this consignment device by the hospitals central sterilising department.In this relation, the instructions for cleaning, sterilization, inspection and maintenance can be pointed out.In this instruction are all required cleaning and inspection steps prepare medical devices for re-use described.A review of the device history was not possible because the lot number was not communicated.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 any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL SLEEVE LOCKING AXSOSTI, 4.3MM DRILL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 12183559
• Report Number: 0008031020-2021-00309
• Device Sequence Number: 1632196
• Product Code: LXH
• UDI-Device Identifier: 04546540694218
• UDI-Public: 04546540694218
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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: 703792
• Device Catalogue Number: 703792
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1