MAUDE Adverse Event Report: STRYKER GMBH 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	45-20001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported the screwdriver bit broke off at the tip when screwing in an asnismicro screw 2.0mm inside the situs.It remains unknown at this time whether remnants of the broken bit remain in the surgical site.No adverse consequence or clinically significant surgical delay were reported.
Event or Problem Description
It was reported the screwdriver bit broke off at the tip when screwing in an asnismicro screw 2.0mm inside the situs.It remains unknown at this time whether remnants of the broken bit remain in the surgical site.No adverse consequence or clinically significant surgical delay were reported.Additional information received ((b)(6)2021) indicate that no debris were left in the patient's body.
Additional Manufacturer Narrative
Please note corrections/updates to sections b5 and h6 (clinical signs code).The reported event could be confirmed, since the tip of the screwdriver is broken off as complained.The device inspection revealed the following: the visual inspection has shown that the tip of the screwdriver is broken off, no fragments were returned for evaluation.The breakage surface of the device shows relatively smooth surface without any great abrupt features; however, the breakage is slightly uneven.Absence of plastic deformation indicates that the breakage was instantaneous (brittle fracture) due to high torsional and bending overload.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.A review of the device history for the reported lot did not indicate any abnormalities.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.Based on investigation, the root cause was attributed to be user related.The breakage shows typical signs of torsional and bending overload applied on the screwdriver during the surgery.If more information is provided, the case will be reassessed.

• Brand Name: 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12320609
• Report Number: 0008031020-2021-00364
• Device Sequence Number: 17278520
• Product Code: LXH
• UDI-Device Identifier: 04546540534385
• UDI-Public: 04546540534385
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: 45-20001
• Device Catalogue Number: 45-20001
• Device Lot Number: 1000372161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2019
• 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