MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREWDRIVER ASNIS III HEX 2.5MM ELASTOSIL HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	40-20905S
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported, "orif was performed for ankle fracture using variax 2 fibula plate and asnis 4.0mm.X-ray taken after the plated was placed to the target site revealed that there was what appeared to be a piece of metal at the site.The metal piece was removed from the patient and the procedure was completed.".
Event or Problem Description
As reported, "orif was performed for ankle fracture using variax 2 fibula plate and asnis 4.0mm.X-ray taken after the plated was placed to the target site revealed that there was what appeared to be a piece of metal at the site.The metal piece was removed from the patient and the procedure was completed.".
Additional Manufacturer Narrative
Please note corrections/updates to the following: section d: product long description, product code, common device name, manufacturer, catalog #, lot/serial no., gtin section g: manufacturing site for devices section h: labeled for single use, usage of device the reported event could be confirmed.The device inspection revealed the following: the identification of the returned cannulated screw was confirmed based on the catalog # and the lot # marked.The tip of the instrument is broken, the detached fragment was returned.The surface of the breakage give indication of a sudden brittle fracture, most probably due to excessive bending and/or torsional load during implantation.The scratches visible on the elastosil handle and its discoloration give evidence that the screwdriver was used multiple times and underwent multiple cycles of sterilization.It also must be noted that the device was used for almost 20 years, meaning that breakage may be expected due to natural wear of the device.Dimensional and material integrity inspection show the device to be according to specification.Based on investigation, the root cause was attributed to a combination of user and natural wear related issue.The failure was most probably cause by excessive load applied to the already worn out instrument.The device was manufactured in 2003.A product history review was not necessary since the device is older than 15 years and no similar complaint was previously opened for the same lot number.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 more information is provided, the case will be reassessed.

• Brand Name: CANNULATED SCREWDRIVER ASNIS III HEX 2.5MM ELASTOSIL HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16660552
• Report Number: 0008031020-2023-00124
• Device Sequence Number: 19234814
• Product Code: LXH
• UDI-Device Identifier: 04546540112262
• UDI-Public: 04546540112262
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023
• 2 Devices were Involved in the Event: 1 2

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: 40-20905S
• Device Catalogue Number: 702478
• Device Lot Number: G06324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male