MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW IMN SCREWS Ø5X45MM; SCREW, FIXATION, BONE

Model Number	2360-5045S
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could be confirmed, since the tip of the broken extractor is stuck in the hexagon recess of the screw.The device inspection revealed the following: the visual inspection of the received locking screw has shown that the broken tip of the extractor is stuck in the hexagon recess of the screw.The head of the screw is strongly deformed and there is a deep groove on one side of the shaft below the screw head.The top of the screw head is also strongly damaged.These damages at the head were most likely caused after the extractor broke to remove the screw with the help of a hollow reamer and a forceps.Otherwise are the thread flanks at the shaft intact, there is no indication for a cold welding or any other issue that could have impaired the extraction of the screw.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.No product related issue could be detected.There was no information provided why an extractor has to be used for the extraction of the screw.An extractor is typically used after the hexagon recess did get damaged by high loads or/and an insufficient connection, during screw insertion or extraction.Based on the available information was the screw implanted for more than 2 years, so increased ingrowth may have played a certain role.If more information is provided, the case will be reassessed.
Event or Problem Description
One item broke during the surgery, male extractor 4mm.The item snapped during use, removing a screw.From my knowledge the item was being used correctly.The operation was to remove a t2 alpha nail implanted in france over 2 years ago.It is unclear if any debris was left in the patient.Additionally: the returned locking screw does show that the removal of the screw was finally successful.The only consequence we are aware of is the 40 minutes delay that was caused by the breakage of the extractor.

• Brand Name: LOCKING SCREW IMN SCREWS Ø5X45MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 16997851
• Report Number: 0009610622-2023-00173
• Device Sequence Number: 15220731
• Product Code: HWC
• UDI-Device Identifier: 07613327366211
• UDI-Public: 07613327366211
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K191271
• 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
• Report Date (Section B): 05/24/2023

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: 10/31/2023
• Device Model Number: 2360-5045S
• Device Catalogue Number: 23605045S
• Device Lot Number: K0E83EB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2018
• 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