MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 LCP CLAV HK PL 6H 18 HK DPTH/73/RT-S; PLATE,FIXATION,BONE

Model Number 241.096S

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

Patient Problems Non-union Bone Fracture (2369); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional 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 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.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 had a nonunion, lateral fracture.Lcp clavicular hook plate 3.5 was used with grafton paste, 5cc.There was a reoperation due to dps implants and hardware removal, patient could feel implant.Union was not achieved.Patient outcome is unknown.No further information is available.This complaint involves 1 (one) device.This report is for (1) 3.5 lcp clav hk pl 6h 18 hk dpth/73/rt-s.This report is 1 of 2 for (b)(4).

• Brand Name: 3.5 LCP CLAV HK PL 6H 18 HK DPTH/73/RT-S
• 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: 12484704
• MDR Text Key: 271797444
• Report Number: 2939274-2021-05474
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982165855
• UDI-Public: (01)10886982165855
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061753
• 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: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 241.096S
• Device Catalogue Number: 241.096S
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR