MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA 5X35 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5035S
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
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 upon opening the 5x35mm t2 locking screw the device inside the packaging was measured at 33mm.The case was completed with a different screw.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.Review of the dhr revealed no discrepancies.The device returned was documented as faultless prior to distribution without reported discrepancies.Evaluation revealed that the reported issue could not be confirmed; the screw length is inside specifications.The engraved length is the nominal length (35 mm).According to the specification the tolerated minor length is 33,5mm.Thus, the length of the locking screw with 33,79 mm is within specified parameters.Screw head length was minimized with design change to decrease soft tissue irritation.Finally, the instructions for screw length determination are described in detail in the corresponding operative technique.
Event or Problem Description
It was reported that upon opening the 5x35mm t2 locking screw the device inside the packaging was measured at 33mm.The case was completed with a different screw.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA 5X35 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11476823
• Report Number: 0009610622-2021-00417
• Device Sequence Number: 19967865
• Product Code: HSB
• UDI-Device Identifier: 04546540202482
• UDI-Public: 04546540202482
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K032244
• 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): 05/28/2021

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 Expiration Date: 10/31/2025
• Device Model Number: 1896-5035S
• Device Catalogue Number: 18965035S
• Device Lot Number: K0EA869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1