MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE INSERTER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 03.037.024

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This complaint is confirmed as the device was received damaged. The user is reported to have damaged the complaint device. There was no indication that a design or manufacturing issue contributed to the complaint. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Device history lot: part number: 03. 037. 024, lot number: t145415, manufacturing site: (b)(4), release to warehouse date: 15-mar-2017. A review of the device history records was performed for the finished device lot number, and no non-conformances were identified. Device history batch: null. Device history review: null. 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, during hip surgery, the surgeon had a helical blade stuck in a nail and had to damage instruments to get it out. There was a surgical delay of forty-five (45) minutes. The procedure was successfully completed. Patient status is unknown. Concomitant devices reported: helical blade (part # unknown, lot # unknown, quantity 1), helical blade inserter (part # 03. 037. 024, lot # t145415, quantity 1), helical blade/screw coupling screw (part # 03. 037. 026, lot # l234221, quantity 1), 130 degree aiming arm (part # 03. 037. 013, lot #l282383, quantity 1), blade/screw guide sleeve (part # 03. 037. 017, lot # l274027, quantity 1). This report is for one (1) helical blade inserter. This is report 3 of 3 for (b)(4).

• Brand Name: HELICAL BLADE INSERTER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11344487
• MDR Text Key: 232573482
• Report Number: 2939274-2021-00946
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070401
• UDI-Public: (01)10886982070401
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• 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: 02/03/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 03.037.024
• Device Catalogue Number: 03.037.024
• Device Lot Number: T145415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown