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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 10/10/2008

Event Type  Injury  

Event Description

It was reported that on literature review "proximal femoral osteotomies in children using the richards hip screw: techniques, outcome and subsequent removal", (4) patients experienced superficial wound infections after an osteotomy using chs (compression hip screws).Patients required oral antibiotics.Complications were resolved at the end of the treatment.No further information is available.

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.

Manufacturer Narrative

Section h10: given the nature of the alleged incident, the devices, could not be returned for evaluation.The clinical/medical investigation concluded that, the literature article was reviewed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.However as of the date of this medical investigation, patient-specific supporting clinical documentation has not been provided.Therefore, there were no clinical factors found which would have contributed to the event.Per complaint details, infections were resolved at the end of treatment with antibiotics.No further clinical/medical investigation is warranted at this time.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported events include loss of sterility during procedure, patients reaction, and post-operative healing issue.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 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.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: 15665616
• MDR Text Key: 302334657
• Report Number: 1020279-2022-04549
• 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

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 11/17/2022
• 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