MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 LCP X-ARTC DSTL HUM PL 6H/LT 158 LG; PLATE, FIXATION, BONE

Model Number 02.104.026

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Clinical code injury.Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: product was not returned therefore no further investigation 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 (information or/and material), 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 hardware removal and re-plating.Patient fell and broke the plate.It is unknown if there is surgical delay reported and if the procedure was successfully completed.Concomitant devices reported: unknown screws (part# unknown; lot# unknown; quantity: unknown).This complaint involves 1 device.This report is for 1 3.5 lcp x-artc dstl hum pl 6h/lt 158 lg.This report is 1 of 1 for (b)(4).

• Brand Name: 3.5 LCP X-ARTC DSTL HUM PL 6H/LT 158 LG
• 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 wrights lane east; west chester, PA
• MDR Report Key: 11821066
• MDR Text Key: 250846797
• Report Number: 2939274-2021-02355
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982029126
• UDI-Public: (01)10886982029126
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.104.026
• Device Catalogue Number: 02.104.026
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention