MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ASSEMBLY (UPPER LEVEL) PRINT, RP 360° SUTURE PASSER NEEDLE, BOX OF 5, OEM FROM I; NEEDLE, SUTURING, DISPOSABLE

Catalog Number 3910-900-091

Device Problem Break (1069)

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

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.We are filing on behalf of the legal manufacturer coorstek.(b)(4).

Event Description

It was reported that the needle tip broke and remained inside of the patient.The procedure completed successfully.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: tip broke.Probable root cause: needle tip was lodged in the tendon of the shoulder.It is possible the tendon was thicker or tougher at this point which contributed to the breakage.Where the product has not ben returned for evaluation the exact root cause could not be identified.Where the surgeon made the decision to not remove the small piece of needle it shows there is very minimal risk to the patient.The needle is composed of biocompatible materials.The failure mode will be monitored for future reoccurrence.(b)(4).

Event Description

It was reported that the needle tip broke and remained inside of the patient.The procedure completed successfully.

• Brand Name: ASSEMBLY (UPPER LEVEL) PRINT, RP 360° SUTURE PASSER NEEDLE, BOX OF 5, OEM FROM I
• Type of Device: NEEDLE, SUTURING, DISPOSABLE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: victoria milich ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6205021
• MDR Text Key: 63308285
• Report Number: 0002936485-2016-01242
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/08/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3910-900-091
• Device Lot Number: 992658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2015
• 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): Other