MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CONDYLE SCREW T2 FEMUR Ø5X75 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1895-5075S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that "as we have just discussed by telephone, i am sending you an e-mail to inform you of an incident concerning the placement of a retrograde s2 femur nail on monday.Indeed, when the transcondylar screw was placed in compression, it never screwed in despite the 1.8 pin and the drilling on both sides of the condyle." additional information received: "the procedure was completed correctly but without this transcondylar compression screw.No clinical consequences to date.Yes, the procedure was delayed by about 20 minutes.No additional medical intervention, but we used the image intensifier more than usual, which could have had repercussions on the patient and the personnel present.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported that "as we have just discussed by telephone, i am sending you an e-mail to inform you of an incident concerning the placement of a retrograde s2 femur nail on monday.Indeed, when the transcondylar screw was placed in compression, it never screwed in despite the 1.8 pin and the drilling on both sides of the condyle." additional information received: "the procedure was completed correctly but without this transcondylar compression screw.No clinical consequences to date.Yes, the procedure was delayed by about 20 minutes.No additional medical intervention, but we used the image intensifier more than usual, which could have had repercussions on the patient and the personnel present.".
Additional Manufacturer Narrative
The reported event that could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the returned device shows signs of usage evident by intense scratches on the shaft of the screw.Appearance of heavy scratches on the screw surface and deformation of the head indicate that the insertion and/or extraction of the screw required great amount of force, possibly caused due to misalignment, consequently interacting with the nail and the washer.Some portion of the threads look flattened with faded anodization which is also indicative of the fact that the screw was not inserted properly and was rather misaligned.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause of the issue is user related as evident by the signs of misaligned insertion.If more information is provided, the case will be reassessed.

• Brand Name: CONDYLE SCREW T2 FEMUR Ø5X75 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14102939
• Report Number: 0009610622-2022-00131
• Device Sequence Number: 11963382
• Product Code: HSB
• UDI-Device Identifier: 04546540202185
• UDI-Public: 04546540202185
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K014220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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: 01/31/2026
• Device Model Number: 1895-5075S
• Device Catalogue Number: 18955075S
• Device Lot Number: K027A8F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown