MAUDE Adverse Event Report: ROTATION MEDICAL, INC. NOT PROVIDED; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Catalog Number NOT PROVIDED

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/04/2019

Event Type  malfunction  

Event Description

It was reported that during procedure, one end of the prong of the tendon staple fixation device broke off after use.The broken tip was unable to locate on the sterile field.If the tip was retained, doctor would not attempt to remove it.Two fluoroscopy were taken post procedure, but there was no object noted on the films.It is unknown if there was a delay or if a backup device was available and how the issue was resolved.

Manufacturer Narrative

The products were not returned for evaluation and therefore a physical investigation could not be completed.Although the issues experienced by the user facility were unable to be confirmed through direct physical investigation, the issue will be monitored for trending purposes.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ¿patient information ¿surgical procedure/post-operative care review ¿device labeling (including technique guides, ifus, etc.) no relevant clinical medical information was provided to conduct a thorough medical assessment.

• Brand Name: NOT PROVIDED
• Type of Device: MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): ROTATION MEDICAL, INC.; 15350 25th ave. no., suite 100; plymouth MN
• MDR Report Key: 8830767
• MDR Text Key: 207936160
• Report Number: 3009351468-2019-00103
• Device Sequence Number: 1
• Product Code: OWY
• Combination Product (y/n): N
• PMA/PMN Number: K122048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NOT PROVIDED
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1