MAUDE Adverse Event Report: NEWDEAL SAS SOLUS - IMPACTOR SOLUS 90AND 26; FOREFOOT II

Catalog Number 229102ND

Device Problem Mechanical Problem (1384)

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

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported the forefoot solus impactor does not hold the solustaple properly.Product was in contact with the patient; however, no patient injury was reported and the event did not led to surgical delay.

Manufacturer Narrative

Udi - (b)(4).Complaint sample was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

Manufacturer Narrative

Solus impactor was returned for evaluation: dhr - no anomalies failure analysis - product was found in compliance.However, it was observed that the staple 26° can move very lightly under pressure when it is hold in the solustaple impactor.The impactor can be used normally even if the staple slightly move.Root cause - the issue is confirmed.Even if the returned device was found in compliance within specifications, the 26° staple can slightly move when it is hold in the impactor.

Event Description

N/a.

• Brand Name: SOLUS - IMPACTOR SOLUS 90AND 26
• Type of Device: FOREFOOT II
• Manufacturer (Section D): NEWDEAL SAS; 97 allee alexandre borodine; 97 allee alexandre borodine; saint priest 69800 ; FR 69800
• MDR Report Key: 10812660
• MDR Text Key: 219517098
• Report Number: 9615741-2020-00012
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2021

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 Catalogue Number: 229102ND
• Device Lot Number: FT6C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 11/30/2020; 09/27/2021
• Supplement Dates FDA Received: 12/16/2020; 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1