MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG (MDR) LOCKING SCREWS, SELF DRILLING, 2.0X8MM, 5/P; IMPLANT

Catalog Number 50-20598

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/11/2015

Event Type  malfunction  

Event Description

It was reported that the tip of the device (product # 50-20598) detached from the body of the screw during a mandible fracture case.This occurred while tightening the wire.

Manufacturer Narrative

The device has been received at the manufacturer for testing.An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.

Manufacturer Narrative

The product was returned for investigation and the reported event (intraoperative screw breakage) could be confirmed.The investigation results show 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 investigation with sem shows on the breakage surface the typical flow structures of a ductile torsional breakage/deformed honeycomb structure caused by high torsional loads during the turn in.A contributing factor to the breakage could have been a too hard bone.The investigated failure modes (intraoperative screw fracture) and the related root cause (too high torsional forces) can be attributed to a user related event.Summarizing the investigation the screw already broke during the insertion and not during wiring as initially reported.Based on the evaluation no indications for any design, material or manufacturing related problems were found in this investigation.

Event Description

It was reported that the tip of the device (product # (b)(4) detatched from the body of the screw during a mandible fracture case.This occured while tighteneing the wire.

• Brand Name: LOCKING SCREWS, SELF DRILLING, 2.0X8MM, 5/P
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG (MDR); boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG (MDR); boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: kelli dykstra ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 4797919
• MDR Text Key: 5815051
• Report Number: 0008010177-2015-00111
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50-20598
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2015
• 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