MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - GUIDE/COMPRESSION/K-WIRES; NAIL, FIXATION, BONE

Device Problem Device-Device Incompatibility (2919)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2020

Event Type  malfunction  

Manufacturer Narrative

510 k: this report is for an unk.Guide/compression/k-wires/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 Description

It was reported that on (b)(6) 2020, during a tfna procedure, the surgeon reported binding between the drill bit and the nail when opening the lateral cortex for the fenestrated screw.The surgeon confirmed the nail degree and aiming arm matched with a drop test and conducted with both guide sleeves / trocars.Currently, it is suspected this occurred due to perhaps two things: first, a very slight flexion between the aiming arm and the insertion handle when adjusting for anteversion.With a tight incision that adjustment could push the deep tissue against the trocar, and the small flex could cause misalignment.During this case, however, he did not have to adjust much if at all.Second repeated forceful mallet blows can sometimes back out the connecting screw between the handle/nail enough to allow for minute play between the two.So, we're getting screw backing out, but it's our suspicion, otherwise, we need to report this.No one else was hurt.There was no time loss maybe a couple of seconds.The procedure was completed successfully.The patient outcome was fine.Concomitant device reported: unk - impaction inst: hammer/mallet: (part# unknown; lot# unknown; quantity: unknown).This complaint involves nine (9) devices.This report is for (1)unk - guide/compression/k-wires.This is report 8 of 9 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Brand Name: UNK - GUIDE/COMPRESSION/K-WIRES
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10824488
• MDR Text Key: 216010092
• Report Number: 2939274-2020-05126
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Patient Sequence Number: 1
• Treatment: 10MM CANNULATED TAPERED DRILL BIT; 11MM/130 DEG TI CANN TFNA 170MM - STERILE; TFNA FENESTRATED SCREW 100MM - STERILE; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA; UNK - NAIL INSERTION HANDLES; UNK - SCREWS: TRAUMA
• Patient Age: 69 YR