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
Medical Device Problem Codes	Biocompatibility (2886); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3015967359-2021-02726
• Device Sequence Number: 4848732
• Product Code: HAW
• UDI-Device Identifier: 57613154107396
• UDI-Public: 57613154107396
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male