MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PIN PASSING 2.4MM TROCAR 17; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	7207220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during a acl reconstruction, while drilling the femoral canal with a pin passing 2.4mm trocar the pin broke into two fragments.The small piece got stuck in the patient's femur and the large piece was removed immediately.To extract the small fragment, the surgeon had to drill a channel in the femur with a cannulated drill of 4.5 mm, punching on the remainder of the pin, thereby drilling a wider channel so that the fragment of the pin fragment could freely exit the bone.Surgery was resumed after a delay greater than 60 min, but it is unknown how the procedure was finished.The current health status of the patient is unknown.
Event or Problem Description
It was reported that, during a acl reconstruction, while drilling the femoral canal with a pin passing 2.4mm trocar the pin broke into two fragments.The small piece got stuck in the patient's femur and the large piece was removed immediately.To extract the small fragment, the surgeon had to drill a channel in the femur with a cannulated drill of 4.5 mm, punching on the remainder of the pin, thereby drilling a wider channel so that the fragment of the pin fragment could freely exit the bone.Surgery was resumed after a delay greater than 60 min with a back-up device.The patient was discharge with recovery.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).The reported device was received for evaluation.It was determined the device did not contribute to the reported event.A complaint history review concluded this was an isolated event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the customer provided image found the device is fractured into two pieces.A visual inspection of the returned device found that it is not in its original packaging.The device is worn from use, and is twisted and fractured near the distal end.There is debris on the device.No relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.

• Brand Name: PIN PASSING 2.4MM TROCAR 17
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13142470
• Report Number: 1219602-2022-00011
• Device Sequence Number: 17329639
• Product Code: LXH
• UDI-Device Identifier: 03596010375315
• UDI-Public: 03596010375315
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2022

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 Expiration Date: 11/13/2023
• Device Model Number: 7207220
• Device Catalogue Number: 7207220
• Device Lot Number: 50770558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 01/06/2022; 03/02/2022
• Initial Report FDA Received Date: 01/03/2022
• Supplement Report FDA Received Date: 01/17/2022; 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 75 KG