MAUDE Adverse Event Report: OSTEOMED .035 X 4" DOUBLE TROCAR K-WIRE

Catalog Number	316-0119
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The ø.035" x 4" double trocar guide wire, p/n 316-0119, was not returned for evaluation.The patients' finger became infected two weeks post-op.This device was used during the surgery, but has not been determined to be the cause of the infection.Possibilities that could have caused the infection are numerous.One possibility is that this, or another instrument or implant, was not sterilized properly.It may be a possibility that the patient had a pre-existing infection prior to the surgery.It may be a possibility that the infection was introduced after the surgery.It may be a possibility that the surgery site was contaminated during surgery.It was reported that the instruments and implants were sterilized pre-op, and that the patient did not have an infection pre-op.The root cause for the infection discovered two weeks post-op could not be determined.There was no lot number provided.Therefore, a review of the device history record for that lot could not be performed.A two-year review did not identify any capas or ncrs related to this instrument.The guide wire is a part of the extremifix 2.0/2.4 cannulated screw system.Although there is no proof that the guide wire caused any infection, this would be the worst risk to review.The risk of an infection due to an unsterile guide wire is covered in the fmea.The potential cause has a severity rating of 4.Per the risk management procedure, a rating of 4 indicates a "critical" severity level (results in permanent impairment requiring professional medical intervention).The final predicted risk level is "high".The extremifix 2.0/2.4mm instruction for use informs the user that guide wires are single use instruments that cannot be reused and/or reprocessed.Doing so might lead to potential risks of cross infection/contamination associated with using inadequately cleaned and sterilized devices.The ifu warns that use of this instrument is contraindicated in cases of active or suspected infection or in patients who are immunocompromised; in patients previously sensitized to titanium; or in patients with certain metabolic diseases.Finally, the ifu states this instrument is supplied non-sterile and must be sterilized prior to use.This issue will be monitored through routine trending.
Event or Problem Description
On december 27, 2018, osteomed was notified of an issue with our.035 x 4" double trocar k-wire.The physician performed a case on (b)(6) 2018 where he put a osteomed screw in a dip fusion left index.Two (2) weeks later the patient has an infection on the operative site.

• Brand Name: .035 X 4" DOUBLE TROCAR K-WIRE
• Common Device Name: .035 X 4" DOUBLE TROCAR K-WIRE
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• MDR Report Key: 8260573
• Report Number: 2027754-2019-00001
• Device Sequence Number: 16182756
• Product Code: HWC
• UDI-Device Identifier: 00845694031226
• UDI-Public: 00845694031226
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K090522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2018

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: 316-0119
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 01/18/2019
• 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: 67 YR