MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING SCREWS, CROSS-PIN, DIAM.2.0X6MM, (5/PACKAGE); IMPLANT

Catalog Number 50-20506

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.

Event Description

It was reported by a company representative that during implantation the thread of the locking portion of the locking screw was no longer attached to the screw.However, the locking thread portion of the screw was recovered, and returned, and the screw was left in the patient.

Manufacturer Narrative

The reported event could be confirmed, the metal coil was sheared off a screw.There are two possibilities where the coil originated from: -cut of the locking thread: during insertion of the screw with too much axial forces, no proper locking could be achieved.Because of a collision with a hard material (no bone; most likely the plate), a coil/sliver was sheared of the screw.-cut of the thread: during inserting the screw the thread collided with a hard material (no bone; most likely the plate).Based on the statistical evaluation there are no indications for any systematic design, material or manufacturing related issue.The complaint is added to the complaint trend.

Event Description

It was reported by a company representative that during implantation the thread of the locking portion of the locking screw was no longer attached to the screw.However, the locking thread portion of the screw was recovered, and returned, and the screw was left in the patient.

• Brand Name: LOCKING SCREWS, CROSS-PIN, DIAM.2.0X6MM, (5/PACKAGE)
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: jonathan schell ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 5834969
• MDR Text Key: 51743314
• Report Number: 0008010177-2016-00163
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 50-20506
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2016
• Initial Date FDA Received: 07/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1