MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM; PLATE,FIXATION,BONE

Model Number	241.351
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter is patient¿s father.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 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) 2019 the patient had surgery at (b)(6) for a broken radius.A synthes implant, tubular plate 1/3 collar with five (5) holes, was used to stabilize the bone.On (b)(6) 2019, patient felt a ¿pop¿ and was taken to emergency room; upon performing x-ray, it was found that the plate broke.On (b)(6) 2019, the patient had a follow- up surgery to remove and replace the broken plate with a new one at (b)(6).The broken plate was sent to pathology for analysis.Pathology report stated that the plate broke due to a manufacturing defect on it.Concomitant devices reported: unknown screw (part# /lot#: unknown, qty # 1).This complaint involves one (1) device.This report is for one (1) lcp one-third tubular plate with collar 5 holes/57mm.This is report is 1 of 1 for (b)(4).
Additional 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.
Event or Problem Description
It was reported on (b)(6) 2019 , the patient went to the emergency room with his parents and was noted to have a monteggia fracture, radial head dislocation and a fracture of the proximal third of the ulna.He does have weakness to lifting thumb and wrist.The patient was indicated for emergent intervention.A 5-hole locking one-third tubular plate was placed in the lateral aspect of the ulna.It was determined to use a 5-hole plate instead of a 7-hole plate because of the patient's age, quality of the bone and the fact that it was a locking system, which is equivalent to 3 cortices below and 3 cortices above the fracture under fluoroscopic guidance in good position.Excellent position and alignment was noted of the fracture fragment, and the dislocation of the radial head back into anatomic position in the ap and lateral views.Drill holes were created, and the one-third tubular locking plate was seated rigidly down onto the lateral aspect of the ulna and then 2 locking screws were then inserted, one proximal, one distal to the fracture after being measured appropriately.On an unknown date, a patient who was wrestling with his left arm straight, when another person slammed their bodyweight into the arm.There was a reported snapping sound, no loss of sensation and notes gross deformity with decreased range of motion.On (b)(6) 2019, the patient had a x-ray and evidently the plate had broken.Approximately 2-1/2 weeks ago after surgery, he claims that he heard a pop, snap and had severe swelling of his left arm.X-rays noted that he had a hardware failure where the plate broke in 2 and there was a displacement of greater than 10 degrees of the proximal ulna fracture with translation of approximately 5mm.The patient underwent a revision on the same day for an open reduction and internal fixation (orif) , left ulna fracture.The screws were taken out and the plate fractured piece was taken out and sent to pathology.A 3.5 locking 5-hole plate was used which was thicker than the original plate.The old screw holes were used, 4 locking, 2 proximal and 2 distal, after being measured to the appropriate screw length and then a non locking screw was used for the middle screw hole.Concomitant devices reported: unknown screw (part #: unknown, lot #: unknown, quantity # 1).This complaint involves one (1) device.This report is for one (1) lcp one-third tubular plate with collar 5 holes/57mm this is report is 1 of 1 for (b)(4).
Additional 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.H10 additional narrative: a1, b5, b6, b7, g3.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
Further it was reported that on (b)(6) 2019, the patient visited a clinic for a follow-up status post his revision orif of the proximal ulna fracture.He is doing well.He has minimal complaints of pain.The patient has no complaints and has full range of motion of his left arm.X-ray shows complete union of the left ulna with callus formation and hardware intact.Well-healed scars, palpable callus non tender left forearm.

• Brand Name: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9172442
• Report Number: 2939274-2019-61349
• Device Sequence Number: 11363262
• Product Code: HRS
• UDI-Device Identifier: 10886982166852
• UDI-Public: (01)10886982166852
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2019

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
• Operator of Device: Health Professional
• Device Model Number: 241.351
• Device Catalogue Number: 241.351
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 11/13/2019; 01/23/2020
• Initial Report FDA Received Date: 10/09/2019
• Supplement Report FDA Received Date: 11/14/2019; 02/03/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA.; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 16 YR
• Patient Weight: 54