MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL FLUTED 2.6MM FOR 2.3MM ANCH; BIT, DRILL

Catalog Number	72201824
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate 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 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 an arthroscopy, an osteoraptor anchor was placed, but when tying the sutures down, the anchor pulled out of the hole.The next 3 anchors when in without an issue.Then, a 5th osteoraptor had the same issue as the first one and pulled out as knot was getting tied.The surgeon mentioned that all the anchors felt loose when pushing into bone through the guide.The drill was inspected and it looked to be slightly bent at the tip so potentially drilled bigger holes.The procedure was completed with a surgical delay of less than 30 minutes using a different drill bit.For the first anchor that pulled out of the bone hole, a 2.9 osteoraptor was placed as a back-up in the original drilled bone hole, and for the fifth anchor that also pulled out, a 2.3 osteoraptor was placed as a back-up, but, in an additional drilled bone hole.No further complications were reported.
Additional Manufacturer Narrative
H11: h2: corrected data on: b5.
Event or Problem Description
It was reported that during an arthroscopy, an osteoraptor anchor was placed, but when tying the sutures down, the anchor pulled out of the hole.The next 3 anchors when in without an issue.Then, a 5th osteoraptor had the same issue as the first one and pulled out as knot was getting tied.The surgeon mentioned that all the anchors felt loose when pushing into bone through the guide.The drill was inspected and it looked to be slightly bent at the tip so potentially drilled bigger holes.The procedure was completed with a surgical delay of less than 30 minutes using a different drill bit.For the first anchor that pulled out of the bone hole, a 2.3 osteoraptor was placed as a back-up, but, in an additional drilled bone hole, and for the fifth anchor that also pulled out, a 2.9 osteoraptor was placed as a back-up in the original drilled bone hole.No further complications were reported.

• Brand Name: DRILL FLUTED 2.6MM FOR 2.3MM ANCH
• Common Device Name: BIT, DRILL
• 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: 20784884
• Report Number: 1219602-2024-02613
• Device Sequence Number: 12024910
• Product Code: HTW
• UDI-Device Identifier: 03596010648068
• UDI-Public: 3596010648068
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/27/2024

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: 72201824
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 72201992; 72201992; 72201993
• Patient Sex: Unknown