MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X60MM TL20MM; SCREW, FIXATION, BONE

Model Number	325060
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/19/2021
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
It was reported that during installation of the screw the leading edge thread from an asnis3 4.0mm pt screw separated from the screw and was left in the patient.Adverse event: leading edge thread from an asnis3 4.0mm pt screw separated from the screw and was left in the patient.Medical intervention : attempts made to remove the detached thread with hooks, instruments etc.Surgical delay: 20 min.
Event or Problem Description
It was reported that during installation of the screw the leading edge thread from an asnis3 4.0mm pt screw separated from the screw and was left in the patient.Adverse event: leading edge thread from an asnis3 4.0mm pt screw separated from the screw and was left in the patient.Medical intervention : attempts made to remove the detached thread with hooks, instruments etc.Surgical delay: 20 min.
Additional Manufacturer Narrative
Please note corrections to d9/h3; the device was not returned and h6; method, results and conclusion codes were updated.The reported event could be confirmed, since a fragment of the screw is visible on the received x-rays.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.Based on the provided information the mentioned lack of pre-drilling and patients hard bone may have played a certain role.In this relation following statement of the asnis iii cannulated screw system operative technique (as-st-2, rev 2, 11-2016) can be pointed out: [the self-cutting and self-tapping tip of the asnis 4.0mm screw is intended for cancellous bone.In dense cortical bone pre-drilling with the cannulated drill ø2.7mm ((b)(6)and use of the cannulated tap ø4.0mm ((b)(6) is recommended, especially when placing oblique screws] [original statement] 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 the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X60MM TL20MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12459694
• Report Number: 0008031020-2021-00411
• Device Sequence Number: 1194289
• Product Code: HWC
• UDI-Device Identifier: 07613327078138
• UDI-Public: 07613327078138
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K000080
• 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): 12/13/2021

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: 325060
• Device Catalogue Number: 325060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 88 KG