MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 100/95; NAIL, FIXATION, BONE

Catalog Number	71677100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an internal fixation surgery performed on (b)(6) 2024, the compression screw portion of the lag/comp screw kit 100/95 was found to be broken off.The fractured screw was not noticed before preforming the revision.It subsequently broke off at the hex making it impossible to utilize the hex driver for removal.After serval hours and attempts.Finally came out after making an osteotomy, a metal cutting bur to cut the nail and a conical reamer over the compression screw.The surgeon was eventually able to remove the lag and nail that were initially implanted.The patient left surgery in good health.No injury to patient.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

• Brand Name: LAG/COMP SCREW KIT 100/95
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20825275
• Report Number: 1020279-2024-02533
• Device Sequence Number: 8843338
• Product Code: JDS
• UDI-Device Identifier: 03596010563323
• UDI-Public: 3596010563323
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K210980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71677100
• Device Lot Number: 23JT76864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 12/02/2024
• Date Device Manufactured: 09/18/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown