MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 7.5MM; BIT, SURGICAL

Model Number	72204041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use in a knee arthroscopy, the surgeon started to drill and the retrograde drill split on the attachment point.The procedure was completed with non-significant surgical delay and was finished with a smith and nephew back up device.No patient complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.A visual inspection of the returned device found that it is not in its original packaging.The proximal end of the shaft is broken, and there is debris on the device.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Our clinical investigation concluded: it was communicated via e-mail that no fragments fell inside the patient.The procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: RETROGRADE DRL 7.5MM
• Common Device Name: 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: 13923366
• Report Number: 1219602-2022-00446
• Device Sequence Number: 6357160
• Product Code: GFG
• UDI-Device Identifier: 00885554037708
• UDI-Public: 00885554037708
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 72204041
• Device Catalogue Number: 72204041
• Device Lot Number: 4997202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 03/26/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown