MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ELITE COMP IMPL KIT 20X20X20 2 LEGS; STAPLE, FIXATION, BONE

Model Number EL-2020S2

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Exact date of event is unknown; event occurred sometime between the original implant procedure on (b)(6) 2021 and the revision procedure on (b)(6) 2021.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 Description

It was reported that on (b)(6) 2021, the patient underwent a removal surgery of the 20/20 elite compression implant due to implant failure after a gynecology procedure.When the patient was moved into stirrups, the open-book pelvic reduction was lost.The initial surgery was done on (b)(6) 2021.The revision surgery was completed with a 6.5 mm cannulated screw and a 145 mm drill bit.The outcome of the procedure was good.This report is for an elite compression implant.This is report 1 of 1 for (b)(4).

• Brand Name: ELITE COMP IMPL KIT 20X20X20 2 LEGS
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES BME : SAN ANTONIO; 14785 omicron drive; #205; san antonio TX 78245
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12413471
• MDR Text Key: 269521077
• Report Number: 2939274-2021-05117
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633021699
• UDI-Public: (01)00810633021699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EL-2020S2
• Device Catalogue Number: EL-2020S2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2021
• 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
• Treatment: UNK - DRILL BITS: TRAUMA; UNK - SCREWS: 6.5 MM AND 7.3 MM CANNULATED
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR