MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RAPTORMITE 3.0 PK W/NDL, 2 #0 ULTRABRA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72201806

Device Problem Material Deformation (2976)

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

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during an arthroscopy procedure, the raptormite implant took out from the implant box insert to patient bone, the anchor suture very soft and bend and difficult to insert repair.It was like broken.The procedure was successfully completed using a back-up device.There was a surgical delay greater than 30 minutes and no further complications were reported.

Manufacturer Narrative

The reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The insertion device was returned with the anchor and suture string.The proximal end of the anchor is deformed and it is leaning off the insertion device.There is biological debris on the returned items.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.The root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: RAPTORMITE 3.0 PK W/NDL, 2 #0 ULTRABRA
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, 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: 18909630
• MDR Text Key: 337739647
• Report Number: 1219602-2024-00508
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010619082
• UDI-Public: 03596010619082
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K071586
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72201806
• Device Lot Number: 2101796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Date Device Manufactured: 10/03/2022
• 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