MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE; STAPLE, FIXATION, BONE

Model Number	72203290
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Perforation (2001); Rupture (2208); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a shoulder joint glenoid labrum repair surgery, the suture of three (3) osteoraptor broke up while being knotted after the anchor was inserted.The procedure was successfully completed with a significant delay using a s+n back-up device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a shoulder joint glenoid labrum repair surgery, the suture of three (3) osteoraptor broke up while being knotted after the anchor was inserted.The procedure was successfully completed with a significant delay using a s+n back-up device in an additional hole.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found 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.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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.A review of the suture found that a material certification is required with each lot.A visual inspection of the returned device found that it is not in its original packaging.Three devices were returned with no anchors.Device 1 the insertion device was returned with broken suture material, the frayed ends of the suture material and the insertion device have debris on them.Device 2 the insertion device was returned with broken suture material.The frayed ends of the suture material and the insertion device have debris on them.The insertion device has scratches near the distal end.Device 3 the insertion device was returned with broken suture material, the frayed ends of the suture material and the insertion device have debris on them.A review of the customer provided images finds the complaint device and frayed suture material.Based on the condition of the product material found during visual inspection, additional material testing is not required.Further patient impact beyond the surgical delay cannot be determined.However it has been reported that the patient¿s current status is good.No further medical assessment is warranted at this time 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 excessive force or torsion during use or use of sharp instruments near the device tip.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.Correction in h6 (health effect - clinical & impact coding).
Additional Manufacturer Narrative
Corrected data: h6: health effect - clinical and impact code.

• Brand Name: OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE
• Common Device Name: STAPLE, 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15731070
• Report Number: 1219602-2022-01676
• Device Sequence Number: 17943170
• Product Code: JDR
• UDI-Device Identifier: 00885554022254
• UDI-Public: 00885554022254
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (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,Followup,Followup
• Report Date (Section B): 07/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2026
• Device Model Number: 72203290
• Device Catalogue Number: 72203290
• Device Lot Number: 2070569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 11/08/2022; 03/13/2023; 06/29/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 11/11/2022; 03/14/2023; 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR
• Patient Sex: Male