MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLEXIBLE DRILL 35MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71362935

Device Problems Fracture (1260); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2022

Event Type  Injury  

Event Description

It was reported that, during surgery, flexible drill 35mm bent and fractured.It is unknown how pieces were retrieved.Surgery was not delayed.Patient was not harmed.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a revision surgery to exchange a non-s+n product for redapt, the flexible drill 35mm bent.The bit did not fracture, but it was useless once it coiled, so more drilling was required.Incision time increased as the procedure extended for 5 min.There was not any additional complication.

Manufacturer Narrative

H11: corrected data in b5 and h6 (health effect - clinical code, health effect - impact code and medical device problem code).Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the device did not actually fracture in pieces during the procedure, it just got bent., therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.

• Brand Name: FLEXIBLE DRILL 35MM
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 15697154
• MDR Text Key: 302682483
• Report Number: 1020279-2022-04602
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010464668
• UDI-Public: 03596010464668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

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 Model Number: 71362935
• Device Catalogue Number: 71362935
• 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: 10/29/2022
• Supplement Dates Manufacturer Received: 10/27/2022
• Supplement Dates FDA Received: 11/14/2022
• 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