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

Catalog Number UNKNOWN

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Fall (1848); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Deformity/ Disfigurement (2360); Impaired Healing (2378); Ambulation Difficulties (2544); Malunion of Bone (4529)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, after a fall sustained on (b)(6) 2021 which involved an intertrochanteric fracture of the right hip, the patient underwent a percutaneous pinning surgery where three (3) cannulated screws (one measuring 85 and the other two measuring 80) from an unknown brand were implanted for fracture reduction.It has been alleged that, due to a negligent procedure where the three (3) implanted screws had an unspecified manufacturing and/or design defects, the patient developed pain, limited mobility, emotional distress and a malunion of the fracture ending up in a hip deformity, as the three (3) screws became loose and hindered a proper healing of the patient¿s intertrochanteric fracture.The screws were revised on (b)(6) 2021, but it is unknown if an additional prosthesis was implanted in exchange.The patient¿s outcome is unknown.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.No relevant supporting clinical information has been provided to assist with a clinical investigation.Patient impact: the patient's current condition is unknown, and the patient impact would be, pain, limited mobility, emotional distress, and a mal-union of the fracture ending in a hip deformity she suffered.Awaiting additional clinical information be provided, to re-open this complaint to be fully evaluated.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, osteolysis, traumatic injury, procedural/user error, surgical/post operative complications, healing issues, patient condition, patient reaction or postoperative care.The contribution of the devices to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices 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.

Manufacturer Narrative

Additional information: a2 (date of birth), a4, b7, d6b.Corrected data: b3, b5, h6 (health effect - clinical code, health effect - impact code, medical device problem code).

Event Description

It was reported that, after a fall sustained on (b)(6) 2021 which involved an intertrochanteric fracture of the right hip, the patient underwent a percutaneous pinning surgery where three (3) cannulated screws (one measuring 85 and the other two measuring 80) from an unknown brand were implanted for fracture reduction.It has been alleged that, due to a negligent procedure where the three (3) implanted screws had an unspecified manufacturing and/or design defects, the patient developed pain, limited mobility, emotional distress, ambulation difficulties and a malunion of the fracture ending up in a hip deformity, as the three (3) screws became loose and protruded into the joint space as revealed on x-rays, hindering a proper healing of the patient¿s intertrochanteric fracture.The screws were removed under direct fluoroscopic visualization on (b)(6) 2021.During this procedure, it was noted that there was some motion of the femoral head with internal and external rotation.The patient was advised that he may require further surgical intervention due to a malunion of the previous fracture.

Manufacturer Narrative

The devices were not returned for evaluation; therefore, devices analysis could not be performed.The clinical/medical investigation concluded that, the surgeon noted the patient¿s bone was ¿relatively soft and the threads on the screw only at the ends to allow it to slide.¿ this cannot be ruled out as a likely contributing factor to the reported screws loosening and protruding, inadequate healing of the femoral neck fracture, pain, limited mobility, and ambulation difficulties.It cannot be concluded that the reported clinical symptoms are related to a malperformance of the implant or implant failure.The impact to the patient beyond the reported screw removal cannot be determined.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file and prior actions review could not be performed.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Additional factors that could contribute to the reported event include size selected or insertion technique.Based on this investigation, the need for corrective action is not indicated.Should the devices 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: 15350049
• MDR Text Key: 299187854
• Report Number: 1020279-2022-03930
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/28/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 09/29/2022; 01/24/2023; 04/27/2023
• Supplement Dates FDA Received: 09/30/2022; 02/21/2023; 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 68 KG