MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING SCREWS, CROSS-PIN, DIAM.2.0X14MM, (5/PACKAGE); IMPLANT

Catalog Number 50-20514

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/22/2017

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 the company representative that the surgeon tried to tighten the screw and the screw head broke off.There was no delay in the surgery.The plate used was a (b)(4).

Manufacturer Narrative

The reported event could be confirmed.In the related ti 4856/17 it was stated: ¿one locking screw, cross-pin, 2.7xxmm broken during surgery, was returned in order to determine the root cause of the failure.The returned screw was examined regarding its dimensions, chemical composition (edx analysis) as well as by light and scanning electron microscopy.The (measurable) dimensions are in accordance with the specification.The chemical composition conforms to the specification - tial6v4 (ti grade 5).The investigation shows that the screw broke as a result of too high torsional forces in forced rupture mode during the insertion.The fracture surface shows the typical flow structures of a ductile torsional breakage.The root cause of the failure could have been a too small diameter or a too low deepness of the pilot hole.Indications for material or manufacturing related problems were not found in this investigation.¿ no corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.

Event Description

It was reported by the company representative that the surgeon tried to tighten the screw and the screw head broke off.There was no delay in the surgery.The plate used was a 92-10505.

• Brand Name: LOCKING SCREWS, CROSS-PIN, DIAM.2.0X14MM, (5/PACKAGE)
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 6837399
• MDR Text Key: 84648793
• Report Number: 0008010177-2017-00223
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

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: 50-20514
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/01/2017
• Supplement Dates Manufacturer Received: 08/22/2017
• Supplement Dates FDA Received: 02/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1