MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN CHS COMPRESSION HIP SCREW PLATE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number UNKNOWN

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

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888)

Event Date 09/27/2000

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Adams, c.I., & robinson, c.M.(2001).Cm court-brown, and m.M.Mcqueen,¿prospective randomized controlled trial of an intramedullary nail versus dynamic screw and plate for intertrochanteric fractures of the femur,¿.Journal of orthopaedic trauma, 15(6), 394-400.Doi: 10.1097/00005131-200108000-00003.

Event Description

It was reported that, on literature review "prospective randomized controlled trial of an intramedullary nail versus dynamic screw and plate for intertrochanteric fractures of the femur", eighty eight (88) patients who underwent primary implantation with an intramedullary hip screw and plate to reduce intertrochanteric femoral fractures required a blood transfusion in a postoperative period of forty eight (48) hours sustained by a mean of hemoglobin levels in blood of 100.9 g/l.The mean operative blood loss in this group was of 260.4 ml.No further information is available.

Manufacturer Narrative

Additional h6 code (health effect - clinical code) was added.H10.The devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the article noted eighty eight (88) patients who underwent primary implantation with an intramedullary hip screw and plate to reduce intertrochanteric femoral fractures required a blood transfusion in a postoperative period of forty eight (48) hours sustained by a mean of hemoglobin levels in blood of 100.9 g/l with a mean operative blood loss in this group was of 260.4 ml.Reportedly, there is no contact information available for this literature case; therefore, patient specific supporting documentation has not been provided as of the date of this medical investigation.The clinical root cause of the reported blood loss cannot not be further assessed; however, post-operative blood loss/anemia is a known possible risk with any surgical procedure and is not indicative of a malperformance of the component(s).The patients¿ outcomes beyond that which was documented in the article cannot not be determined as the patients¿ current health status remains unknown.No further medical assessment 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.Some potential probable causes that could contribute to the reported event have been identified as patient reaction 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 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.

• Brand Name: UNKN CHS COMPRESSION HIP SCREW PLATE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 14843903
• MDR Text Key: 295023092
• Report Number: 1020279-2022-03141
• Device Sequence Number: 1
• Product Code: KTT
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• 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: 07/28/2022
• 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
• Treatment: UNKN CHS COMPRESSION HIP SCREW
• Patient Outcome(s): Other