MAUDE Adverse Event Report: ETHICON INC. SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE; STAPLE, IMPLANTABLE

Catalog Number STRAP12

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Other (for use when an appropriate patient code cannot be identified) (2200); Therapy/non-surgical treatment, additional (2519)

Event Date 03/11/2015

Event Type  Injury  

Event Description

It was reported that a patient underwent laparoscopic inguinal hernia repair on (b)(6) 2015 and absorbable straps were used to secure the mesh.During the procedure, the strap went through the patient¿s skin and nicked the glove and finger of the surgical technician.The strap did not have to be physically removed.The surgical technician was treated at employee health and underwent a blood test for hep b which was negative and no further treatment was provided.It was reported that the surgical technician is fine and returned to work the same day.The patient was very thin and the surgeon opined that this was a contributing factor to the event.

Manufacturer Narrative

(b)(4).Date sent to the fda: 04/08/2015.(b)(4).Conclusion : the product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Conclusion: actual device was returned for evaluation.Visual and functional inspections were performed and no visual damage was noted and the device worked as intended.According the ifu the total distance from the surface of the tissue to the underlying bone, vessels, or viscera should be evaluated prior to application and should be a minimum of 6.7 mm.

• Brand Name: SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 3260 4; MX 32604
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4668695
• MDR Text Key: 5604078
• Report Number: 2210968-2015-04136
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: STRAP12
• Device Lot Number: HMM808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 04/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention