MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN CANNULATED SCREWS SCREW; PLATE, FIXATION, BONE

Catalog Number UNKNOWN

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case-(b)(4).Zhu, z.D., xiao, c.W., tan, b., tang, x.M., wei, d., yuan, j.B.,.& feng, l.(2021).Tirobot-assisted percutaneous cannulated screw fixation in the treatment of femoral neck fractures: a minimum 2-year follow-up of 50 patients.Orthopaedic surgery, 13(1), 244-252.Doi: 10.1111/os.12915.

Event Description

On the literature article named "tirobot-assisted percutaneous cannulated screw fixation in the treatment of femoral neck fractures: a minimum 2-year follow-up of 50 patients", it was reported that, after cannulated screws screw had been implanted on 1 patient, during conventional internal fixation surgery using three 7.3 mm diameter cannulated screws to treat an unilateral femoral neck fracture, two screws penetrated the femoral neck from the inferior side while being inserted.This was not noticed during surgery.Further details on how was this incident resolved are unknown.The patient outcome is unknown.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the data presented was from a literature review article that reported, after cannulated screws screw had been implanted on 1 patient, during conventional internal fixation surgery using three 7.3 mm diameter cannulated screws to treat an unilateral femoral neck fracture, two screws penetrated the femoral neck from the inferior side while being inserted.This was not noticed during surgery.Per the compliant, further information is not available.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.In addition, the images have been interpreted within the text; therefore, no further analysis of the images are required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional clinically relevant information be provided, this complaint would be re-assessed.A complaint history review found related failures for the listed product type; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: UNKN CANNULATED SCREWS SCREW
• Type of Device: PLATE, 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: 12624398
• MDR Text Key: 276161439
• Report Number: 1020279-2021-07554
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 11/16/2021
• Supplement Dates FDA Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other