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

Model Number	72204043
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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
• Common Device Name: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11221309
• Report Number: 1219602-2021-00189
• Device Sequence Number: 11708806
• Product Code: GFG
• UDI-Device Identifier: 00885554037722
• UDI-Public: 00885554037722
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2024
• Device Model Number: 72204043
• Device Catalogue Number: 72204043
• Device Lot Number: 4906208
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: Not provided
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention