MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYNOMITE 2.0 PK W/NDL 12-0 ULTRABRAID; STAPLE, FIXATION, BONE

Model Number 72201881

Device Problem Crack (1135)

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

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during an ankle ligament repair, the dynomite anchor cracked.The procedure was successfully completed using a back-up device.It is unknown if there was a delay.No other complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of the material found there are requirements for conformance and a certificate of material analysis is required.A review of the customer provided image confirms the batch number and product number.The image also reveals the anchor is not attached at the distal tip of the device.No physical damage visible in image.A relationship, if any, between the subject device and the reported event could not be determined.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: DYNOMITE 2.0 PK W/NDL 12-0 ULTRABRAID
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12334500
• MDR Text Key: 267036557
• Report Number: 1219602-2021-01737
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010619068
• UDI-Public: 03596010619068
• Combination Product (y/n): N
• PMA/PMN Number: K081511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201881
• Device Catalogue Number: 72201881
• Device Lot Number: 2062804
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1