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	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported "as discussed this evening, the operating room has reported an incident encountered on each screwdriver for the locking screw (ref.# (b)(4)) of our two gamma 3 nail ancillaries.Black debris was found on the coils of these two screwdrivers when opening each of the boxes.We wonder about the nature of this debris, the hypothesis of dried blood inside the spires being preferred.The sterilization agents brushed as much as possible at the level of these coils, but these being very tight, it is not possible to brush inside nor to ensure us of the state of the instrument inside these coils.The two boxes being necessary for the night in case of emergency, and not having a spare screwdriver or any other alternative, these boxes were returned to the block after an important manual brushing at the level of the coils, then passage of the whole material in washer-disinfector and in autoclave.".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported "as discussed this evening, the operating room has reported an incident encountered on each screwdriver for the locking screw (ref 1320-0233) of our two gamma 3 nail ancillaries.Black debris was found on the coils of these two screwdrivers when opening each of the boxes.We wonder about the nature of this debris, the hypothesis of dried blood inside the spires being preferred.The sterilization agents brushed as much as possible at the level of these coils, but these being very tight, it is not possible to brush inside nor to ensure us of the state of the instrument inside these coils.The two boxes being necessary for the night in case of emergency, and not having a spare screwdriver or any other alternative, these boxes were returned to the block after an important manual brushing at the level of the coils, then passage of the whole material in washer-disinfector and in autoclave.".
Additional Manufacturer Narrative
Correction: please refer to h6 health impact code.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received set screwdriver shows significant traces of frequent use as evident by scratches on the shaft and worn-out surfaces.The reported event could be confirmed as cleaning is impaired which is evident from the presence of black spots or residue on the spiral even after 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 material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to user related issue.The failure was caused by not clearly following the cleaning technique during sterilization.¿medical devices with flexible shaft reusable medical devices with a flexible shaft are considered as demanding instruments regarding cleaning.In each case, the instructions for cleaning, sterilization, inspection and maintenance shall be strictly followed.The automated cleaning process should be preferred over the manual method and used whenever possible.The automated cleaning process has a higher reproducibility and reliability.[¿] caution: remove contamination from shafts right after use to avoid incrustation, which will be baked permanently in subsequent sterilizations.¿ [original statement(s)] if any further information is provided, the complaint report will be updated.
Event or Problem Description
The customer reported "as discussed this evening, the operating room has reported an incident encountered on each screwdriver for the locking screw (ref (b)(4)) of our two gamma 3 nail ancillaries.Black debris was found on the coils of these two screwdrivers when opening each of the boxes.We wonder about the nature of this debris, the hypothesis of dried blood inside the spires being preferred.The sterilization agents brushed as much as possible at the level of these coils, but these being very tight, it is not possible to brush inside nor to ensure us of the state of the instrument inside these coils.The two boxes being necessary for the night in case of emergency, and not having a spare screwdriver or any other alternative, these boxes were returned to the block after an important manual brushing at the level of the coils, then passage of the whole material in washer-disinfector and in autoclave.".

• 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: 13203883
• Report Number: 0009610622-2022-00007
• Device Sequence Number: 5860845
• 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): 05/13/2022

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: 1320-0233
• Device Catalogue Number: 13200233
• Device Lot Number: K713226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 05/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2011
• 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