MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T7, DIAM. 2.7X16MM; PLATE, FIXATION, BONE

Model Number	53-27216E
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2020
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
As reported: "by tightening one of the screws, this gives up what the specialist doesn't like./ when taking intraoperative x-ray, two screws must be removed to reset them, the doctor expresses that the head is already rolled and are additionally toricided.".
Event or Problem Description
As reported: "by tightening one of the screws, this gives up what the specialist doesn't like./ when taking intraoperative x-ray, two screws must be removed to reset them, the doctor expresses that the head is already rolled and are additionally toricided.".
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by an application of large forces while inserting the screws.The device inspection revealed the following: three screws were returned.For one of the screws, only the head was returned.The microscope investigation showed the head of the screws is heavily damaged.Traces of were are clearly shown.This is a clear sign that the insertion of the screws was performed using larges forces.Moreover, one of the screw is completely broken - only the head was returned.This leads to say that excessive over-tightening was applied on the devices.The ifu clearly reminds the user to avoid subjecting the screws to an excessive tightening.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.If any further information is provided, the complaint report will be updated.

• Brand Name: BONE SCREW, T7, DIAM. 2.7X16MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10589321
• Report Number: 0008031020-2020-02274
• Device Sequence Number: 3028066
• Product Code: HRS
• UDI-Device Identifier: 07613154913992
• UDI-Public: 07613154913992
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K080667
• 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): 12/10/2020

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: 53-27216E
• Device Catalogue Number: 53-27216E
• Device Lot Number: 1000391866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR