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 Hematoma (1884)

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", (2) patients developed a wound hematoma after a osteotomy using chs (compression hip screws).Complication was evacuated surgically.Complications were resolved and this had no long-term sequelae.No further information is available.

Manufacturer Narrative

H3, h6: given the nature of the alleged incident, the devices were not returned for evaluation and the reported event could not be confirmed.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, the complications were resolved with surgery and the patients had no long-term sequalae.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 event include procedural/user error, surgical complication, post-operative healing issue and/or patient condition.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 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: 15665651
• MDR Text Key: 302330162
• Report Number: 1020279-2022-04551
• 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: 11/14/2022
• 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): Other