MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.7X3MM, MIDFACE, (5/PACKAGE); IMPLANT

Catalog Number 50-17903

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)

Patient Problem Failure of Implant (1924)

Event Date 06/09/2017

Event Type  Injury  

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 a post-op inspection after a mandibular distraction surgery on (b)(6) 2017 it was determined the patient had to be brought back into the or for a revision surgery due to screws not holding plates in place and the bone had stripped causing the screws to come through.

Manufacturer Narrative

A confirmation of the reported event of screw loosening was not applicable since the products were not returned for investigation and sufficient information was not provided.Based on the additional provided information by the sales rep and the information within the ifu, several possible contributing factors to the event can be identified.It was stated that the bone quality of the patient was soft, which has to be considered as contraindicated for the application of the screws and the pmd according to the referenced ifus.Moreover it is recommended to use 1.7 mm self-tapping screws for a patient of an age up to two years in order to provide adequate fixation.In the reported case the patient was a newborn (according to the who definition younger than 28 days old) and 1.7 mm self-drilling screws were used that by contrast were recommended for patients from two to four years.Both the patient¿s soft bone quality and the use of self-drilling screws can be considered as contributing factors to the reported event.Therefore, the root cause can be most likely attributed to a user related handling issue.Due to the soft bone quality (listed as a contraindication in the ifu) in combination with the use of self-drilling screws versus stryker¿s recommendation to use self-tapping screws in such a young patient (newborn), it can be concluded that these factors finally led to the reported screw loosening.These factors are also referenced as root causes in the related risk management files.Based on statistical evaluation there are no indications for any systematic design, material, or manufacturing related issue.Therefore no preventive and/or corrective actions are deemed necessary at this time.The complaint is added to the complaint trend.

Event Description

It was reported by a company representative that during a post-op inspection after a mandibular distraction surgery on (b)(6) 2017 it was determined the patient had to be brought back into the or for a revision surgery due to screws not holding plates in place and the bone had stripped causing the screws to come through.

• Brand Name: BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.7X3MM, MIDFACE, (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: gregory gohl ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 6669349
• MDR Text Key: 78461786
• Report Number: 0008010177-2017-00142
• 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: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50-17903
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2017
• 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