MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEEDTITAN COMPRESSION IMPL KIT 20X15X15; STAPLE, FIXATION, BONE

Model Number SE-2015TI

Device Problem Break (1069)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/24/2022

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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 history lot - part number: se-2015ti, bme lot number: bse180251, manufacturing date or release to warehouse date: 13 apr2018, place of manufacture: (b)(4), lot expiration date: 03 dec2023.Device history review - review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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) 2022 one of the legs of a drilling guide for a speed titan broke off during drilling.An additional incision had to be made to retrieve the broken guide which took roughly fifteen(15)min at the end of the case.This report is for one (1) speedtitan compression impl kit 20x15x15.This is report 1 of 1 for complaint (b)(4).

• Brand Name: SPEEDTITAN COMPRESSION IMPL KIT 20X15X15
• 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): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13903362
• MDR Text Key: 287910688
• Report Number: 2939274-2022-01066
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633021552
• UDI-Public: (01)00810633021552
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2023
• Device Model Number: SE-2015TI
• Device Catalogue Number: SE-2015TI
• Device Lot Number: BSE180251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2018
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1