MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.7X4MM, MIDFACE, (5/PACKAGE); IMPLANT

Catalog Number 50-17904

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/21/2017

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 that part# 62-01321 x 1, per surgeon x-ray that was taken of patient post op, the device was no longer distracting.The device was implanted 2 weeks prior to the patient being called in for an additional surgery, and once the patient was opened it was found that the screws had fallen out of the moving segment of the distractor.The internal distractor was removed and the doctor tried a multiguide distractor but the patient's bone was too brittle.The doctor has chosen to close up the patient and let the bone heal, and address the issue at a later date.No replacement is needed.Product will be returned.Sales rep available for case.No other information is available at this time.

Manufacturer Narrative

The device and catalog number were updated in this supplemental report to reflect the actual event that occurred.A confirmation of the reported event of screw loosening was not applicable since neither the products were returned for investigation nor sufficient information were 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 poor which is 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 patient of an age up to two years in order to provide adequate fixation.In the reported case the patient was three weeks old and self drilling screws were used that were recommended for patients from two to four years.Both the patient¿s poor bone quality and the used self-drilling screw can be considered as contributing factors to the reported event.Therefore, the root cause can be attributed to a user related handling issue.Due to the poor bone quality (listed contraindication in the ifu) in combination with the use of self-drilling screws versus the stryker¿s recommendation to use self-tapping screws in such a young patient ((b)(6) weeks old) it can be concluded that these factors finally led to the reported screw loosening determined within revision surgery.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.Actual screws discarded.

Event Description

It was reported that part# 62-01321 x 1, per surgeon x-ray that was taken of patient post op, the device was no longer distracting.The device was implanted 2 weeks prior to the patient being called in for an additional surgery, and once the patient was opened it was found that the screws had fallen out of the moving segment of the distractor.The internal distractor was removed and the doctor tried a multiguide distractor but the patient's bone was too brittle.The doctor has chosen to close up the patient and let the bone heal, and address the issue at a later date.No replacement is needed.Product will be returned.Sales rep available for case.No other information is available at this time.

• Brand Name: BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.7X4MM, 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: jonathan schell ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 6480199
• MDR Text Key: 72679747
• Report Number: 0008010177-2017-00076
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133398
• 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: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 50-17904
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2017
• 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