MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ACCESS KIT 10 GAUGE-DIAMOND TIP/END-OPENING-STERILE; DEVICE, PERCUTANEOUS, BIOPSY

Model Number	03.804.517S
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot: part: 03.804.517s.Lot: 17b09-2.Manufacturing site: selzach.Supplier: sfm medical devices gmbh.Release to warehouse date: 27.February 2017.Expiry date: 01.February 2022.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2020, while the surgeon performed a balloon vertebroplasty on a patient with a l5 pathologic fracture.The two (2) access kit handles were broken.While placing the access kit needle and trochar via a transpedicular approach, it was found out that the patient had very hard bone.He had to mallet on the top of the blue trochar part of the access kit agressively.After he had the trochar and working sleeve in the position he wanted, he tried to remove the trochar portion and it was stuck.He twisted the blue handle part and kept trying to remove it, but it was anchored into the patients l5 bone.After continuing to try and remove it, the blue handle came off of the trochar shaft.He tried removed the shaft with pliers and other forceps, but was unsuccessful.He ended up removing the working sleeve along with the trochar.This exact thing happened on both the left and right sides.After removing both access kits with the broken trochar handles, he placed 2 new access kits which the nurse opened up.No fragments remained in patient.There was a fifteen (15) minutes surgical delay.Procedure was successfully completed.There was no patient consequence.Concomitant device reported: unknown mallet (part # unknown, lot # unknown, quantity # 1).This report is for one (1) access kit 10 gauge-diamond tip/end-opening-sterile.This is report 2 of 2 for (b)(4).

• Brand Name: ACCESS KIT 10 GAUGE-DIAMOND TIP/END-OPENING-STERILE
• Common Device Name: DEVICE, PERCUTANEOUS, BIOPSY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9726872
• Report Number: 2939274-2020-00891
• Device Sequence Number: 2179732
• Product Code: MJG
• UDI-Device Identifier: 10705034722641
• UDI-Public: (01)10705034722641
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: 03.804.517S
• Device Catalogue Number: 03.804.517S
• Device Lot Number: 17B09-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/19/2020
• Patient Sequence Number: 1
• Patient Age: 61 YR