MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE; SCREW, FIXATION, BONE

Catalog Number	72201995
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known risks with the device itself or with its use 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 a rotator cuff and labrum repair surgery, two (2) units of a osteoraptor 2.9 w/ 2 ub white / blue broke.The procedure was resumed using an equivalent s+n back up.It is unknown if there was a delay, and no further complications were reported.
Event or Problem Description
It was reported that, during a rotator cuff and labrum repair surgery, three (3) units of a osteoraptor 2.9 w/ 2 ub white / blue were fractured.The procedure was resumed using an equivalent s+n back up.It is unknown if there was a delay, and no further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H2: corrected data on b5, e2 & h8.H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found three devices lying on a surgical cloth.The insertion devices have no visible defects but the anchors and sutures strings are off the shaft.The tip of one of the anchors is fractured.The poor image quality makes it impossible to confirm the reported anchor breakage on the other two anchors.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found 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 material specifications found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.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 improper/excessive force or torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H11: h3, h6 the reported devices were received for evaluation.A visual inspection revealed that two devices were each returned in original packaging with the batch number of the complaint on the label.Device one, the anchor was returned off the device with no visible defect.No sutures were returned.The insertion device has no visible defect.Device two, the anchor was returned off the device with no visible defect.One white suture was returned off the anchor.It has no visible defect.The insertion device has no visible defect.A complete material assessment could not be performed due to the blue/white sutures not being returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found 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 material specifications found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include improper/excessive force or torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE
• Common Device Name: SCREW, FIXATION, BONE
• 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: 24167755
• Report Number: 1219602-2026-00230
• Device Sequence Number: 15850476
• Product Code: HWC
• UDI-Device Identifier: 03596010615565
• UDI-Public: 3596010615565
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151105
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2026

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: 72201995
• Device Lot Number: 2153591
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 02/18/2026; 04/30/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/19/2026; 05/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2024
• 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