MAUDE Adverse Event Report: ROTATION MEDICAL BIOINDUCTIVE IMPLANT - MEDIUM; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Catalog Number 2169-2

Device Problems Migration or Expulsion of Device (1395); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation narrative: additional information has been requested from the complainant regarding this incident and the investigation is currently ongoing.

Event Description

It was reported that during an arthroscopic rotator cuff repair, the surgeon deployed the regeneten patch implant into the shoulder and in doing so he "lost" the implant.Implant could not be located and is presumed to be still in the patient.A back-up device was available to complete the procedure however, the incident resulted in a surgical delay greater than 30 minutes.No patient injury or other complications were reported.

• Brand Name: BIOINDUCTIVE IMPLANT - MEDIUM
• Type of Device: MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): ROTATION MEDICAL; 15350 25th avenue north; suite 100; plymouth MN 55447
• Manufacturer (Section G): ROTATION MEDICAL; 15350 25th avenue north; suite 100; plymouth MN 55447
• Manufacturer Contact: garrett ahlborg ; 15350 25th avenue north; suite 100; plymouth, MN 55447 ; 7637467531
• MDR Report Key: 8333849
• MDR Text Key: 139078766
• Report Number: 3009351468-2019-00003
• Device Sequence Number: 1
• Product Code: OWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 2169-2
• Device Lot Number: RC2AN18M7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1