MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72201996

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2024

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference:(b)(4).

Event Description

It was reported that during a knee arthroscopy, the osteoraptor suture anchor broke when inserted into the hole.The procedure was completed using a s+n back up device.There was no surgical delay.No further complications were reported.

Manufacturer Narrative

H10: h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not 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 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 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.A clinical review states that based on the limited information provided the clinical root cause of the reported events could not be determined and we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.The device ifu does caution that ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device.¿ the osteoraptor anchor is implantable, biocompatibility is not an issue.If fragments from the broken osteoraptor anchor were retained, local irritation/discomfort, and/or migration of the anchors should not be ruled out.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.

• Brand Name: OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 19175365
• MDR Text Key: 341134410
• Report Number: 1219602-2024-00874
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 03596010615572
• UDI-Public: 03596010615572
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K151105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 72201996
• Device Lot Number: 2089390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/24/2024
• Date Device Manufactured: 03/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Male