MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SET SCREWDRIVER, FLEXIBLE SHAFT GAMMA3® 4 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-0233
Medical Device Problem Codes	Device Reprocessing Problem (1091); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
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
It was reported that, "flexible screwdriver 1320-0233 (stryker brand) present in the gamma clou boxes whose design does not allow either: clean it properly - control its cleanliness during re-composition.Despite the training of operators in cleaning and the scrupulous human controls carried out during recomposition (this box was recomposed by a nurse who was well aware of the problem: she indicated that she had twisted the spring to check its cleanliness between the coils and had not detected any residue), this screwdriver was identified as dirty when the box was opened in the operating room.It is likely that it is organic residue trapped inside the spring and vaporized by pressurized steam during the autoclave process.As this undesirable event has been a problem during surgery with potential consequences for the operated patient, we have asked stryker to carry out the necessary investigations and to propose an alternative (e.G.: old sheathed model?) to this model of unsheathed screwdriver.Current status of the patient: dm essential for surgery at no other box available.Patient under spinal anesthesia.The screwdriver is cleaned with saline and the soiled part is isolated with a drain.The surgeon was obliged to use this device as it was.".
Event or Problem Description
It was reported that, "flexible screwdriver 1320-0233 (stryker brand) present in the gamma clou boxes whose design does not allow either: - clean it properly - control its cleanliness during re-composition.Despite the training of operators in cleaning and the scrupulous human controls carried out during recomposition (this box was recomposed by a nurse who was well aware of the problem: she indicated that she had twisted the spring to check its cleanliness between the coils and had not detected any residue), this screwdriver was identified as dirty when the box was opened in the operating room.It is likely that it is organic residue trapped inside the spring and vaporized by pressurized steam during the autoclave process.As this undesirable event has been a problem during surgery with potential consequences for the operated patient, we have asked stryker to carry out the necessary investigations and to propose an alternative (e.G.: old sheathed model?) to this model of unsheathed screwdriver.Current status of the patient: dm essential for surgery at no other box available.Patient under spinal anesthesia.The screwdriver is cleaned with saline and the soiled part is isolated with a drain.The surgeon was obliged to use this device as it was".
Additional Manufacturer Narrative
Please note the correction to the h6 device code, component code, and the d9/h3: the reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.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 root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device disposition is unknown.

• Brand Name: SET SCREWDRIVER, FLEXIBLE SHAFT GAMMA3® 4 MM
• 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: 15847691
• Report Number: 0009610622-2022-00553
• Device Sequence Number: 12341695
• Product Code: LXH
• UDI-Device Identifier: 04546540592545
• UDI-Public: 04546540592545
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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: 1320-0233
• Device Catalogue Number: 13200233
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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