MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND 3.0 20X25CM

Catalog Number 606-300-020

Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

One of 2 reports - other mfg report number: 3004170064-2017-00010.It was reported that there are seemingly soapy bubbles formed in the saline while rehydrating.Product was in contact with the patient; however, no patient injury reported and the event did not lead to surgical delay.According to the sales rep: my suggested technique for the larger pieces has not changed when there is not a large enough receptacle to rehydrate the mesh in whilst it is still stiff.I have just never noticed this bubble situation before that i can recall.The process is as such: once the scrub nurse has the sterile inner bag on her table, i suggest they open it just a little in the centre and pour a litre of room temp saline into the bag.Rolling the top of the bag over creates a seal as best possible and the nurse then, holding the bag at each end, creates a rocking motion which in turn, gently sloshes the device in saline and starts the softening or rehydration process.Once the device is suitably soft i get them to pour the water from the bag into a sterile bowel and place the mesh in there in its now softened state where they can fold it to keep it all submerged as best possible.Sometimes an additional liter of saline is added.

Manufacturer Narrative

Integra has completed their internal investigation on september 13, 2017.Results: the failure is unconfirmed, as there was no product returned for this complaint.Therefore, failure analysis could not be performed.Dhr review; no anomalies were found and all manufacturing related process steps were followed and documented per listed instructions and current good manufacturing practices.All qc inspection steps related to labeling inspection were followed as per instructions, no anomalies were found.Complaints history; a query of the complaints database for the timeframe of 03aug2016 ¿ 03aug2017 was performed using the keywords: ¿surgimend,¿ ¿soap,¿ ¿soapy,¿ ¿bubble,¿ ¿rehydrating,¿ ¿rehydrate¿ and ¿rehydration.¿ there was one additional complaint received for this issue on the same day ((b)(6) 2017) and from the same complaint reporter.Including this complaint, there have been a total of two complaints of ¿soapy bubble whilst rehydrating¿ related to surgimend from the past year (03 august 2016 ¿ 03 august 2017).There were approximately 16,729 surgimend units sold in the past 12 months before this complaint resulting in a calculated complaint occurrence rate is 0.01%.Conclusion: root cause is indeterminable.The device was not returned for failure analysis as it remains implanted in the patient.

• Brand Name: SURGIMEND 3.0 20X25CM
• Type of Device: SURGIMEND
• Manufacturer (Section D): TEI BIOSCIENCES INC; 7 elkins street; 7 elkins street; boston MA 02127
• Manufacturer (Section G): TEI BIOSCIENCES INC; 7 elkins street; boston MA 02127
• Manufacturer Contact: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6853687
• MDR Text Key: 86105397
• Report Number: 3004170064-2017-00009
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K083898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/31/2017

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: 606-300-020
• Device Lot Number: 1611005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/08/2017
• Supplement Dates Manufacturer Received: 09/12/2017
• Supplement Dates FDA Received: 09/13/2017
• 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