MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CHS COMPRESSION HIP SCREW; PLATE, FIXATION, BONE

Catalog Number UNKNOWN

Device Problem Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/10/2008

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Webb, j.A., almaiyah, m., mcvie, j., & montgomery, r.J.(2008).Proximal femoral osteotomies in children using the richards hip screw: techniques, outcome and subsequent removal.Journal of children's orthopaedics, 2(6), 417-423.Doi: 10.1007/s11832-008-0127-8.

Event Description

It was reported that on literature review "proximal femoral osteotomies in children using the richards hip screw: techniques, outcome and subsequent removal", (1) patient screw was stripped on the head on attempting to remove the metalwork during a osteotomy using chs (compression hip screws).The metalwork was unable to be removed and the hip screw was leave in situ.No further information is available.

Manufacturer Narrative

H3, h6: the device was 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.Per the literature article, no further information is available.Based on the information provided, the metalwork was unable to be removed and the hip screw was left in situ.The hip screw is comprised of biocomposite material which is intended for implantation.Since the hip screw was left in the bone, the potential for micro-motion/migration is unlikely.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The impact to the patient beyond that which has already been documented in the article could not be confirmed nor concluded based on the information provided; therefore, no further medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case 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.Factors that could contribute to the reported event include surgical technique used or user/procedural variance.The contribution of the device 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 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.We consider this investigation closed.Internal complaint reference number: (b)(4).

• Brand Name: CHS COMPRESSION HIP 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: 15665629
• MDR Text Key: 302335639
• Report Number: 1020279-2022-04550
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 11/17/2022
• Supplement Dates FDA Received: 11/21/2022
• 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): Required Intervention