MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 8MM; BIT, SURGICAL

Catalog Number	72204042
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference case-(b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during set up, when the customer opened the retrograde drill package, it was already opened and the adhesive was missing.A backup device was available, and no surgical delay was reported.There was no patient involvement.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is sealed in its original packaging with an incomplete seal.The outer box is crumpled at one end.A review of the material specifications found that the raw material strength requirements and storage requirements are specified.Also, each lot must be accompanied by a material certificate of analysis.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 complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the device drawings found that a certificate of conformance and a certificate of sterility required.A supplier evaluation was performed and found the shelf carton in which the device was returned had sustained severe damage during shipment to the customer.However, the outer (shipper) box received at viant showed no signs of damage.The end of the tray on the returned device, which was unsealed, sustained damage in the same location as the damaged shelf carton.Upon review, there is evidence (residue) that the tray/lid were completely sealed all around the tray flange.These devices undergo a 300% visual inspection before being shipped to the customer.After sealing and before peel test, the devices are inspected for voids, wrinkles, glazing.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include potential packaging damage due to improper storage, handling or transport.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: RETROGRADE DRL 8MM
• 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: 21402052
• Report Number: 1219602-2025-00397
• Device Sequence Number: 18478037
• Product Code: GFG
• UDI-Device Identifier: 00885554037715
• UDI-Public: 885554037715
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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 Catalogue Number: 72204042
• Device Lot Number: 5521716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2023
• 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