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

Catalog Number UNKNOWN

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

(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, after conventional internal fixation surgery using three 7.3 mm diameter cannulated screws to treat an unilateral femoral neck fracture, one patient had a screw which began slipping and migrating from its original position.This was noticed 3 months postoperatively.12 months postoperatively, the femoral head was displaced again.Further details on how was this adverse event treated are unknown.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the failure mode was confirmed.The clinical/medical investigation concluded that, per the complaint details, no further information is available.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be rendered nor can we determine a definitive clinical root cause of the reported failure.The physicians referenced in the abstract provided an analysis of all the attached images within the text; therefore, no further analysis of the images is 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 relevant patient-specific documentation be provided, this complaint would be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.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.We consider this investigation closed.

• 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: 12624528
• MDR Text Key: 276165035
• Report Number: 1020279-2021-07557
• 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: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• 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
• Date Manufacturer 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
• Patient Age: 52 YR
• Patient Sex: Male