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	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2020
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
As reported: "all three sieves / screwdrivers are dirty after preparation and sterilization after opening the sieve [.].As a result, the or staff had to open a new sieve intraoperatively.Unfortunately, the instruments were also dirty here.The instruments were cleaned by ultrasound and in a water bath under bending - here the note that bending is probably very difficult.There was no additional steam cleaning, as there is a fear that residues may be pushed further "inside".Since such obvious contamination was not noticed during cleaning (even when cleaning again - the dirty but unused instruments have been reprocessed again), it is assumed that the "contamination" is "pulled out" again in the fractionated vacuum process.For this reason, the contamination is only visible after sterilization and opening.Sales rep mentioned the additional cleaning instructions again in the conversation and also mentioned the rigid screwdriver as an alternative.".
Event or Problem Description
As reported: "all three sieves / screwdrivers are dirty after preparation and sterilization after opening the sieve [.].As a result, the or staff had to open a new sieve intraoperatively.Unfortunately, the instruments were also dirty here.The instruments were cleaned by ultrasound and in a water bath under bending - here the note that bending is probably very difficult.There was no additional steam cleaning, as there is a fear that residues may be pushed further "inside".Since such obvious contamination was not noticed during cleaning (even when cleaning again - the dirty but unused instruments have been reprocessed again), it is assumed that the "contamination" is "pulled out" again in the fractionated vacuum process.For this reason, the contamination is only visible after sterilization and opening.Sales rep mentioned the additional cleaning instructions again in the conversation and also mentioned the rigid screwdriver as an alternative.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the all 3 set screwdriver received shows signs of normal usage.An examination revealed that before decontamination there were residue found on the spiral and after the decontamination there were no debris, residuals or particles on the flexible part.There was just a slight discoloration visible on the spring.Optical discoloration was identified as scratches and dents as well as partially significant material abrasion.This was caused by contact with other instrument / implants either intra-operative or during cleaning sterilization.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].Based on the investigation, the root cause was attributed to a user related issue.The failure was caused by not clearly following the cleaning technique during sterilization.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; DE D-24232
• MDR Report Key: 9901489
• Report Number: 0009610622-2020-00133
• Device Sequence Number: 16848607
• Product Code: LXH
• UDI-Device Identifier: 04546540592545
• UDI-Public: 04546540592545
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2020

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: K202050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1