MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP NAV PIN 3MM X 100MM CASE OF 10; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 6007003100

Device Problems Biocompatibility (2886); No Apparent Adverse Event (3189)

Patient Problem Fluid Discharge (2686)

Event Date 11/29/2021

Event Type  Injury  

Event Description

It was reported that five days after a procedure at the user facility fluid was present at the wound site where navlock pins were placed.The pins were noted to have been placed in the region of the patient's tibia.Attempts are being made to obtain additional information from the user facility.

Event Description

It was reported that five days after a procedure at the user facility fluid was present at the wound site where navlock pins were placed.The pins were noted to have been placed in the region of the patient's tibia.The user facility was not able to provide any further information regarding the reported event.

Manufacturer Narrative

Based on the limited information provided and a consultation with the senior medical safety manager, it is likely that serous fluid was leaking from the pin site, which could be found from a post-operative incision or contained within fracture blisters.It is possible that contributing factors in limiting the pin site drainage may be the technique of pin site placement and the avoidance of transcortical drilling, however this was not confirmed.H3 other text : no product return per the customer.

• Brand Name: NAV PIN 3MM X 100MM CASE OF 10
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 13012380
• MDR Text Key: 282321579
• Report Number: 3015967359-2021-02726
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 57613154107396
• UDI-Public: 57613154107396
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

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 Catalogue Number: 6007003100
• Device Lot Number: NR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 03/09/2022
• Supplement Dates FDA Received: 03/09/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male