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 device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.The batch 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.However, the most probable cause of such an event is the inadequate cleaning and reprocessing of the device before use.If any additional information is provided, the investigation 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
• MDR Report Key: 11219963
• Report Number: 0009610622-2021-00249
• Device Sequence Number: 11655612
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• 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