MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG COLORADO NEEDLE, 2 CM STRAIGHT (3/32") SLEEVE; INSTRUMENT

Catalog Number	N110A
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	09/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.Device discarded at facility.
Event or Problem Description
It was reported that wound dehiscence occurred following a procedure, and a follow up procedure was performed to close the wound.The colorado needle was used for skin incision during surgery.
Additional Manufacturer Narrative
It can be concluded that the reported event is not related to the device in question.As initial step of the investigation it was reached out to the medical expert, senior global medical director, regarding a medical assessment of the reported event.Hereby, it was excluded that the device in question did contribute or caused the reported event.Therefore, the complaint is considered as not related to the product and consequently further investigation steps like a complaint or device history review were not deemed necessary.Overall, there is no indication for any systematic design, material or manufacturing related issue.Product surveillance will continue to monitor complaints of this type for adverse trends.
Event or Problem Description
It was reported that wound dehiscence occurred following a procedure, and a follow up procedure was performed to close the wound.The colorado needle was used for skin incision during surgery.

• Brand Name: COLORADO NEEDLE, 2 CM STRAIGHT (3/32") SLEEVE
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7903560
• Report Number: 0008010177-2018-00091
• Device Sequence Number: 1472587
• Product Code: GEI
• UDI-Device Identifier: 04546540004130
• UDI-Public: 04546540004130
• Combination Product (Y/N): N
• PMA/510(K) Number: K033232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: N110A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR