MAUDE Adverse Event Report: STRYKER TRAUMA KIEL AWL, CURVED T2 TIBIA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0041
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
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.
Event or Problem Description
As reported: "on (b)(6) at the sanatrix nursing home, due to a private gamma 3 intervention, an unpleasant inconvenience occurred; shortly before starting the operation, with the patient already anesthetized on the operating table, the instrumentalist checks the gamma 3 instruments on the sterile serving table, after inserting the guide wire into the curved cannulated awl code 18060041, organic material composed of clots of blood and bone leaked onto the sterile serving table in front of the operators.At this point, sterility having been compromised, it was decided to sterilize everything again, to clean the instrument and postpone the surgery for about 40 minutes (with the patient already under deep anesthesia).".
Event or Problem Description
As reported: "on 12 may, at the sanatrix nursing home, due to a private gamma 3 intervention, an unpleasant inconvenience occurred; shortly before starting the operation, with the patient already anesthetized on the operating table, the instrumentalist checks the gamma 3 instruments on the sterile serving table, after inserting the guide wire into the curved cannulated awl code 18060041, organic material composed of clots of blood and bone leaked onto the sterile serving table in front of the operators.At this point, sterility having been compromised, it was decided to sterilize everything again, to clean the instrument and postpone the surgery for about 40 minutes (with the patient already under deep anesthesia).".
Additional Manufacturer Narrative
The device was not returned for evaluation and no other evidences were provided.Nevertheless as the event is rated as confirmed a local capa was opened to address this service related event.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.Based on the provided information it can be concluded that this complaint is not product related, the information indicates that the reprocessing of the awl was not properly carried out.Therefore a local capa was opened in italy to address this consignment related event.If more information is provided, the case will be reassessed.

• Brand Name: AWL, CURVED T2 TIBIA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 14628792
• Report Number: 0009610622-2022-00235
• Device Sequence Number: 12298750
• Product Code: LXH
• UDI-Device Identifier: 04546540377975
• UDI-Public: 04546540377975
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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: 1806-0041
• Device Catalogue Number: 18060041
• Device Lot Number: K146053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2012
• 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