MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5045S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that: "i am contacting you regarding a dispute that has arisen in the orthopaedic surgery on a locking screw reference 18965045s (lot: k09fe39 - implantation deadline: (b)(6) 2025).The surgeon reported that the locking screw thread frayed into the nail during insertion and removal, resulting in extraction difficulties and the creation of intramedullary debris." additional information received from the customer - 09/06/2021: "the operation was completed correctly with a longer operation time of between 15 and 30 minutes and the need for a larger approach due to the need to remove the more difficult material.".
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
Please note corrections to section d1, d4 (catalog number, lot number and gtin) and g4.The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the received locking screw exhibited significant deformation at the screw head and at the threads.The threads look absolutely splayed.The edges have become flat.Most likely the screw was misaligned during insertion, added with high amount of force.The screw head is also observed to be deformed, but that is most likely caused during extraction.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 deemed to be user related.The manner of deformation indicates towards an improper insertion of the screw, most likely involving an interaction with a metallic part (in this case, nail).If any further information is provided, the complaint report will be updated.
Event or Problem Description
The customer reported that: "i am contacting you regarding a dispute that has arisen in the orthopaedic surgery on a locking screw reference (b)(4) (lot: k09fe39 - implantation deadline: 31/12/2025).The surgeon reported that the locking screw thread frayed into the nail during insertion and removal, resulting in extraction difficulties and the creation of intramedullary debris." additional information received from the customer - 09/06/2021: "the operation was completed correctly with a longer operation time of between 15 and 30 minutes and the need for a larger approach due to the need to remove the more difficult material.".

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12505288
• Report Number: 0009610622-2021-00699
• Device Sequence Number: 5169578
• Product Code: HSB
• UDI-Device Identifier: 04546540202505
• UDI-Public: 04546540202505
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

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: 09/30/2025
• Device Model Number: 1896-5045S
• Device Catalogue Number: 18965050S
• Device Lot Number: K093BEA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2020
• 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