MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BME ELITE(TM) IMPLANT KIT 18 X 18 MM, 2 LEGS; STAPLE, FIXATION, BONE

Model Number EL-1818S2

Device Problem Device-Device Incompatibility (2919)

Patient Problem Tissue Damage (2104)

Event Date 08/11/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2020 during a midfoot fusion procedure the handle of the bme elite implant kit would not release the staple implant.The issue happened on back to back implant kits, both have the same lot numbers.The gray portion of the inserter handle was taken out to be able to release the staple implant.The implant had to be explanted then reinserted.More soft tissue was exposed however, additional implants used in case were also problematic.There was a surgical delay.The procedure was completed successfully.This report is for one (1) bme elite(tm) implant kit 18 x 18 mm, 2 legs.This is report 2 of 4 for (b)(4).

• Brand Name: BME ELITE(TM) IMPLANT KIT 18 X 18 MM, 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10509804
• MDR Text Key: 206293728
• Report Number: 2939274-2020-04056
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633021682
• UDI-Public: 00810633021682
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EL-1818S2
• Device Catalogue Number: EL-1818S2
• Device Lot Number: MEL200041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention