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 Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported that : "for information, we met again the issue we had 2 or 3 years ago on the gamma nails: black debris ("cooked" blood?) on the flexible part of the screwdriver, requiring the opening of a 2nd "healthy" instrument set.
Event or Problem Description
The customer reported that : "for information, we met again the issue we had 2 or 3 years ago on the gamma nails: black debris ("cooked" blood?) on the flexible part of the screwdriver, requiring the opening of a 2nd "healthy" instrument set.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device did not show any sign of reported issue.Although an image was shared showing the alleged ¿dirt/residue¿ on one of the screwdrivers, but it could not be traced to a particular screwdriver.Device inspection revealed the following: the received set screwdriver shows significant traces of frequent use as evident by scratches on the shaft and slightly worn out drive.However, the reported event could not be confirmed as no residue (tissue remnants) could be observed coming out through the spiral even when it was inspected first hand before sending it for decontamination at the investigation site.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 manufacturing or design related problems were found during the investigation.A review of the labelling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to an insufficient cleaning and reprocessing at the user end.Since the device didn¿t show any dirt/residue upon inspection at the investigation site, it is most likely the case that originally the device was not cleaned properly as per the instructions, but upon subsequent reprocessing, the device sustained no residue.This proves that sufficient cleaning is possible.However, regarding the concern of a potential harm to the patient due to this: residues on the flexible part were evaluated by a medical expert for a similar complaint.His comments (excerpts): ¿a surgical instrument with residuals of body fluids or human tissue has no increased risk of infection, if a sufficient sterilization procedure has been made (¿sterile crud¿) only in the (very rare) case of significant contamination with body fluids from a previous patient with massive infection of lps producing germs a small load of endotoxins (lps) may cause a limited local inflammation, which will be hardly registered by the patient otherwise, no negative side effects for the patient have to be expected, if a surgical instrument is contaminated with (incrusted) residuals of body fluids or human tissue from previous surgeries due to insufficient cleaning and / or the design of the instrument, which would not allow for perfect cleaning.¿ the general cleanability of the screwdriver in the flexible part was proved during design validation.Tests confirmed that germ reduction is being achieved significantly better with automatic [machine cleaning] as well as manual cleaning for the subject product than for comparable other critical instruments [e.G.Endoscopes].If any further information is provided, the complaint report will be updated.

• 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
• MDR Report Key: 11220319
• Report Number: 0009610622-2021-00246
• Device Sequence Number: 19676633
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: 1320-0233
• Device Catalogue Number: 13200233
• Device Lot Number: K030E1D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 01/23/2021
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1