MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 30MM; NAIL, FIXATION, BONE

Model Number 212.111

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

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.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 Description

It was reported that on an unknown date, a patient fell resulting in a displaced right proximal humerus fracture.On (b)(6) 2009, the patient underwent an open treatment of right proximal humerus fracture with tuberosity repair.Plate and screws were implanted.After the procedure, the patient experienced a reaction at the surgical site for five (5) years.The patient wants the devices removed.At this point no revision procedure has been reported.Concomitant devices: 3.5mm lcp® proximal humerus plate-standard 5h shaft/ 114mm (part 241.903, lot unknown, quantity 1); 3.5mm locking screw slf-tpng w/stardrive(tm) recess 45mm (part 212.119, lot unknown, quantity 3); 3.5mm locking screw slf-tpng w/stardrive(tm) recess 40mm (part 212.117, lot unknown, quantity 1); 3.5mm cortex screw self-tapping 26mm (part 204.826, lot unknown, quantity 3); 3.5mm cortex screw self-tapping 24mm (part 204.824, lot unknown, quantity 1); 3.5mm locking screw slf-tpng with stardrive recess 35mm (part 212.114, lot unknown, quantity 1).This report is for an lcp screw.This is report 5 of 10 for (b)(4).An additional device is captured on related complaint (b)(4).

Manufacturer Narrative

Product complaint # :(b)(4).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: h3, h6: investigation summary: the received pictures were reviewed.There is a reaction, a red spot, at the humerus visible.On the picture it seems to be the left humerus, but it is not clear if the picture is may be mirror inverted as according to the operation report the right humerus was fractured.Only based on this picture is cannot be defined if this reaction is related to the implants, therefore n/a was selected in the confirmed field.Product was not returned and on the pictures with the part numbers are no lot numbers listed, therefore no further investigation is possible.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.H11: g1/updated physical manufacture site provided for reporting.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.

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 Description

Updated event description: it was reported that on an unknown date, a patient fell resulting in a displaced right proximal humerus fracture.On (b)(6) 2009, the patient underwent an open treatment of right proximal humerus fracture with tuberosity repair.Plate and screws were implanted.After the procedure, the patient was experiencing unknown symptoms and was dealing with this for 5 years.The patient wanted the plate and screws to be removed.On (b)(6) 2015, the patient had a check-up due to skin lesion that was located on her right upper arm that was swollen, painful, and enlarging, moderate in severity and has been present for two weeks.This lesion has not been treated in the past.On (b)(6) 2015, the patient who is following up for abscess on the right arm.She was treated with i&d simple or single and labs were ordered.On (b)(6) 2016, the patient underwent an elliptical surgical excision with complex layered closure due to scar revision on the right upper arm.The following repair was indicated to close the resulting wound, reduce anatomic distortion and scarring, and minimize skin tension that could lead to wound infection or dehiscence.On (b)(6) 2019, the scar is growing and itchy and moderate in severity.She has had this scar for years.On (b)(6) 2019, the patient who is following up for keloid on the right upper arm.She was seen on (b)(6) 2019, at which time 1 lesion was injected w/ intralesional kenalog in bacteriostatic water (2.5mg/ml, 1ccs) and she was prescribed bryhali 0.01% lotion.

• Brand Name: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 30MM
• 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: 9861902
• MDR Text Key: 186275802
• Report Number: 2939274-2020-01430
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982151858
• UDI-Public: (01)10886982151858
• Combination Product (y/n): N
• PMA/PMN Number: K072095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 212.111
• Device Catalogue Number: 212.111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2020
• Patient Sequence Number: 1
• Treatment: 3.5MM CORTEX SCREW SELF-TAPPING 24MM; 3.5MM CORTEX SCREW SELF-TAPPING 26MM; 3.5MM LCP® PROXIMAL HUMERUS PLATE; 3.5MM LOCKING SCREW 35MM; 3.5MM LOCKING SCREW 40MM; 3.5MM LOCKING SCREW 45MM
• Patient Outcome(s): Required Intervention