MAUDE Adverse Event Report: STRYKER GMBH EXTRACTOR ASNIS III FOR SCREWS:Ø4.0MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702496
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2019
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: "it was reported that when preparation of surgery to remove asniss after bone fusion, the foreign matter was confirmed on the extractor." procedure was completed successfully with no adverse consequences or surgical delay reported.
Event or Problem Description
As reported: "it was reported that when preparation of surgery to remove asniss after bone fusion, the foreign matter was confirmed on the extractor." procedure was completed successfully with no adverse consequences or surgical delay reported.
Additional Manufacturer Narrative
The reported device was not returned for evaluation.Only debris of skin / blood (the reported foreign matter) were provided.Based on investigation, the root cause was attributed to be maintenance related.The failure was caused by possible inadequate cleaning at the hospital.Nevertheless 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.The device inspection revealed the following: the returned debris is merely parts of skin and dry blood, no metal debris can be found from either the asnis extractor nor from the removed screw.As it was mentioned that this was reported during preparation of the surgery, we could only determine that these depositions were either left on the instrument due to the fact that it was not properly cleaned or it was from the patient.However no further information could be obtained.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.Disposition unknown.

• Brand Name: EXTRACTOR ASNIS III FOR SCREWS:Ø4.0MM AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9079682
• Report Number: 0008031020-2019-01283
• Device Sequence Number: 13969016
• Product Code: LXH
• UDI-Device Identifier: 04546540112415
• UDI-Public: 04546540112415
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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 Catalogue Number: 702496
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 12/24/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1