MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL GUIDE OFFSET FISH M 2.9MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72201391
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference number: (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 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 an arthroscopy procedure for shoulder instability, when placing the anchor, the surgeon used the drill inside the drill guide offset fish m 2.9mm, removed the drill and inserted the anchor, impacting the anchor.He went almost to the end, but it was missing 1 centimeter and when comparing the 2 guides, it was noticed that one was larger than the other.Surgery was completed with a beveled back-up guide.There was no surgical delay, and no further complications were reported.
Additional Manufacturer Narrative
H11: h3, h6: the reported device was not received for evaluation.However, an evaluation of the images provided by the customer showed two devices: the reported device, a drill guide offset fish mouth tip (72201391, lot 50352897) positioned next to a drill guide spike tip (72201388).The reported device (72201391) seems longer than the drill guide spike tip, however at the end of the shaft where the handle initiates, there are some wear lines mask.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 specifications found that the length of the guide shaft is specified to be 6.00 in and the complete device (shaft + handle) to be 10.35 in.During the investigation, it was not possible to identify a definitive root cause as the devices was not returned for evaluation; however, due to the wear line mark observed on the shaft, it was concluded that potential causes for the reported event include damage and/or degradation of the device.The wear line mark may indicate a recessed or loose shaft within the handle, which could explain the difference in length observed between the devices.Based on this investigation, a corrective action is not indicated.

• Brand Name: DRILL GUIDE OFFSET FISH M 2.9MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22002711
• Report Number: 1219602-2025-01107
• Device Sequence Number: 17958551
• Product Code: NBH
• UDI-Device Identifier: 03596010595485
• UDI-Public: 3596010595485
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: 72201391
• Device Lot Number: 50352897
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/08/2025
• Date Device Manufactured: 10/27/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Male