MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X70MM TL23.5MM; SCREW, FIXATION, BONE

Catalog Number	325070S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Remains implanted.
Event or Problem Description
The customer reported that the tip of the screw has broken off and remains in the patient.The surgeon reports no issue with the pre-drill for the screw and the k-wire that the screw was passed over is not bent.The surgeon is satisfied that no additional harm will occur leaving the screw and more damage could occur if it was removed.The tip of the threaded end of the screw broke off, approximately 3 full threads.Patient had good bone.No issues drilling.
Additional Manufacturer Narrative
The reported event (screw breakage during surgery) could be confirmed by the intraoperative images provided.A physical examination of the affected screw was not possible since the device was not returned, and no other evidence was provided.Postoperative x-rays were not provided.Both received images of poor quality are copies of photographs which were taken of a screen intraoperatively; they were forwarded to a consulting healthcare professional for review.The hcp stated that in general cannulated screws can break much easier, and that they can also cut through the k-wires used for localization, which happens even more often.He further indicated that there is no threat to the patient regarding material exposure, if the broken tip is left inside, but it could be slightly more complicated if future operative measurements are necessary.According to the consulting healthcare professional a more precise assessment is not possible due to the poor quality of the received intraoperative images.For comprehensive evaluation postoperative x-rays would be necessary.More detailed information, and in particular the affected device must be available in order to determine the root cause of the intraoperative screw breakage.A review of the device history for the reported lot did not indicate any abnormalities.No indications of manufacturing or design related problems were found during the investigation.No corrective actions are required at this time.The operative technique instructs: ¿note: contact of an asnis iii screw with dense bone in a tangential direction may cause a deviation of the screw and/or a bending of the k-wire, which may result in damage to the implant.¿ based on the limited information provided and without physical examination of the affected screw, the root cause of the reported event cannot be determined.If the device is returned or any further useful information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported that the tip of the screw has broken off and remains in the patient.The surgeon reports no issue with the pre-drill for the screw and the k-wire that the screw was passed over is not bent.The surgeon is satisfied that no additional harm will occur leaving the screw and more damage could occur if it was removed.The tip of the threaded end of the screw broke off, approximately 3 full threads.Patient had good bone.No issues drilling.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X70MM TL23.5MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9099399
• Report Number: 0008031020-2019-01292
• Device Sequence Number: 19333536
• Product Code: HWC
• UDI-Device Identifier: 07613327076257
• UDI-Public: 07613327076257
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 12/18/2019

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 Expiration Date: 01/31/2024
• Device Catalogue Number: 325070S
• Device Lot Number: B90683
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR