MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 8.5MM; BIT, SURGICAL

Model Number 72204043

Device Problem Break (1069)

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

Event Date 01/06/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during an arthroscopy, the retrograde drills broke when the surgeon tried to downshift to pierce the tunnel in the femur.The procedure was completed without significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: RETROGRADE DRL 8.5MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11221309
• MDR Text Key: 234793827
• Report Number: 1219602-2021-00189
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 00885554037722
• UDI-Public: 00885554037722
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

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: 72204043
• Device Catalogue Number: 72204043
• Device Lot Number: 4906208
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: Not provided
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• 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; Required Intervention