MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH

Model Number 5196502400

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, during the insertion of the static anchor, once the anchor was implanted in the patient's left obturator membrane, at some point the metal "tip" of the trocar broke off.The entire 7mm tip was missing from the insertion device after the surgeon removed the device from the patient.At first the introducer was not parallel to the descending pubic ramus when passing both anchors.But after some adjustment on the static side.The insertion phase of the static anchor did meet resistance on 2 attempts to implant.At first resistance, the surgeon lowered his hand to reduce the angle of the device (i.E.Started at 1:00 aim and moved to 2:00) at which time he tried to push the anchor in again.There was still some resistance, but after some additional force quickly "popped" the anchor into place.It is unclear if the anchor hit bone.The static anchor was also initially over-rated and was re-adjusted with under rotation to put into correct position.Patient outcome: surgeon left the static anchor in place, assuming that the metal tip was "stuck" inside of the anchor.He successfully finished implanting the altis.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis, mn
• Manufacturer Contact: sarah o'gara ; 1601 west river road north; minneapolis, mn
• MDR Report Key: 10227890
• MDR Text Key: 197788957
• Report Number: 2125050-2020-00501
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2020

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 Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 6944141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 07/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR