MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: 4.5 MM LCP PROXIMAL FEMUR PLATE; PLATE, FIXATION, BONE

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Pma/510k: this report is for an unk: plates: 4.5 mm lcp proximal femur plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent bilateral femoral extension and internal fixation surgery.The surgeon attached the sleeve in question to the most distal hole of the bended plate to insert the locking screw.When the sleeve was removed after drilling with a drill bit, it was found that the tip of the sleeve was missing.The surgery was completed successfully within 30 minutes delay.No further information is available.Concomitant device reported: unk - bending instruments: plate bender: trauma (part# unknown; lot# unknown; quantity: 1), unk - drill bits: trauma (part# unknown; lot# unknown; quantity: 1), unk - screws: locking (part# unknown; lot# unknown; quantity: 1), unk - guides/sleeves/aiming: guide (part# unknown; lot# unknown; quantity: 1).This complaint involves two (2) devices.This report is for (1) unk: plates: 4.5 mm lcp proximal femur plate.This report is 2 of 2 for (b)(4).

• Brand Name: UNK - PLATES: 4.5 MM LCP PROXIMAL FEMUR PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12276002
• MDR Text Key: 265027278
• Report Number: 2939274-2021-04476
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LCP DRILL SLEEVE 5 F/DRILL BIT Ø4.3; UNK - BENDING INSTRUMENTS: PLATE BENDER: TRAUMA; UNK - DRILL BITS: TRAUMA; UNK - GUIDES/SLEEVES/AIMING: GUIDE; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention