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

Catalog Number 229102ND

Device Problems Partial Blockage (1065); Device Inoperable (1663)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2016

Event Type  malfunction  

Event Description

It was reported the device seemed blocked.The patient was undergoing a forefoot surgery procedure.The patient was under anesthesia when the issue was identified.Due to the problem with the device, the procedure could not be performed.It was reported that although the device was in contact with the patient, no patient injury is alleged.The event led to an unspecified increase in surgery time.

Manufacturer Narrative

Integra has completed their internal investigation on 17may2016.The investigation activities included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: the device involved in this complaint is pn 229102nd lot fble manufactured on 20th february 2015 and (b)(4) items were released.All the released devices were controlled about the reversibility of the anvil regarding (b)(4).All results were compliant.We review the records of the similar incidents during last two years.This is the (b)(4) incident for blocking of solustaple impactor.We take into account the sales of solustaple staples, the impactor being reusable instrument used to handle and insert solustaple.(b)(4).Conclusion: the incident is confirmed but we cannot determine the root cause.

• Brand Name: SOLUS - IMPACTOR SOLUS 90¿AND 26
• Type of Device: FOREFOOT II
• Manufacturer (Section D): NEWDEAL SAS; 97 allee alexandre borodine; 97 allee alexandre borodine; saint priest 69800 ; FR 69800
• Manufacturer (Section G): NEWDEAL SAS; 97 allee alexandre borodine; parc tech de laporte des alpes; saint priest 69800 ; FR 69800
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5636680
• MDR Text Key: 45647530
• Report Number: 9615741-2016-00022
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• 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: FBLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 45 YR