MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L16MM; SCREW, FIXATION, BONE

Model Number	656416
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "incident that has occurred on 5 occasions in the traumatological hospital corresponding to the surgeries that we have tendered with the radio distal variax plate the specific problem is that when the screw 2.7 is placed in the oval hole of the plate, it rolls, does not tighten, it becomes loose, although the length of the screw has been changed several times.The screw box was reviewed by checking the screw head, changing the screwdriver, talking and observing with the assistants and doctors about the technique used".
Additional Manufacturer Narrative
D9 / h3 updated to indicate device was not returned; d4 updated to unknown.The reported event could not be confirmed since the device was not returned for evaluation and only based on the received picture it is not possible to confirm a functional issue.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.A review of the device history was not possible because the communicated lot number is invalid.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.
Event or Problem Description
As reported: "incident that has occurred on 5 occasions in the traumatological hospital corresponding to the surgeries that we have tendered with the radio distal variax plate the specific problem is that when the screw 2.7 is placed in the oval hole of the plate, it rolls, does not tighten, it becomes loose, although the length of the screw has been changed several times.The screw box was reviewed by checking the screw head, changing the screwdriver, talking and observing with the assistants and doctors about the technique used".

• Brand Name: BONE SCREW, T8 FULL THREAD, 2.7MM/L16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11926343
• Report Number: 0008031020-2021-00252
• Device Sequence Number: 16918700
• Product Code: HWC
• UDI-Device Identifier: 07613327068856
• UDI-Public: 07613327068856
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

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: 656416
• Device Catalogue Number: 656416
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1