MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 LCP SUPERIOR CLAV PL/7 HOLE/RT/100; PLATE, FIXATION, BONE

Model Number 02.112.082

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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 conclusion could be drawn at the time of filing this report.The 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 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, the patient underwent a fracture fixation surgery for a shaft fracture utilizing an lcp superior clavicle plate.There was a reoperation due to hardware removal- patient could "feel" plate.There was a known union of fracture after 6 weeks duration and no post-operative complications reported.Patient outcome is unknown.No further information is available.Concomitant devices reported: unk - screws: (part# unknown; lot# unknown; quantity: unknown).This complaint involves nine (9) devices.This report is for (1)3.5 lcp superior clav pl/7 hole/rt/100.This report is 1 of 9 for (b)(4).

• Brand Name: 3.5 LCP SUPERIOR CLAV PL/7 HOLE/RT/100
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12491408
• MDR Text Key: 272133708
• Report Number: 2939274-2021-05540
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982033130
• UDI-Public: (01)10886982033130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 02.112.082
• Device Catalogue Number: 02.112.082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/17/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR