MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG (MDR) BONE SCREWS, EMERGENCY, CROSS-PIN, SELF-TAPPING, DIAM.1.9X5MM MIDFACE, (5/PACKAG; IMPLANT

Catalog Number 50-19005

Device Problems Break (1069); Detachment Of Device Component (1104); Metal Shedding Debris (1804)

Patient Problem No Code Available (3191)

Event Date 03/20/2015

Event Type  malfunction  

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.

Event Description

It was reported that the original implantation surgery for the patient was on (b)(6).The surgeon completed the distraction, and the patient was sent home.The parents of the patient noticed that their child appeared to be experiencing difficulty feeding, and on (b)(6), they were advised to bring the patient back for a check-up.The surgeon felt that one or both implanted devices may have regressed, and the patient was brought back to the or for further investigation.From what we are aware, the surgeon has been successfully able to make the necessary corrections for the patient.Even though the screws did not affect the functionality of the reported distractor, they were returned with the complained distractors.As per the information received, these screws are concomitants.They did not cause or contribute to this event; however, upon investigation it was noted that there was debris on the screw; particles seem to have sheared off, especially at the thread of the screws.

Manufacturer Narrative

The returned screws showed abrasion / damages as a result of collisions with hard metal objects (no bone) and from grabbing and/or holding the screws.As stated in the related instruction for use the implants shall be handled with care, because scratching or damage to the component can significantly reduce the strength and fatigue resistance of the product.During visual inspection of the screws together with the stryker health care professional and material expert it was stated by the health care professional that it is common to use pliers / forceps for grabbing and/or holding very tiny littly screws during screw insertion.Therefore the root cause of the determined abrasion / damages could be attributed to a user related issue (unintended use of medical instruments as a tool).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 original implantation surgery for the patient was on (b)(6).The surgeon completed the distraction, and the patient was sent home.The parents of the patient noticed that their child appeared to be experiencing difficulty feeding, and on (b)(6), they were advised to bring the patient back for a check-up.The surgeon felt that one or both implanted devices may have regressed, and the patient was brought back to the or for further investigation.From what we are aware, the surgeon has been successfully able to make the necessary corrections for the patient.Even though the screws did not affect the functionality of the reported distractor, they were returned with the complained distractors.As per the information received, these screws are concomitants.They did not cause or contribute to this event; however, upon investigation it was noted that there was debris on the screw; particles seem to have sheared off, especially at the thread of the screws.

• Brand Name: BONE SCREWS, EMERGENCY, CROSS-PIN, SELF-TAPPING, DIAM.1.9X5MM MIDFACE, (5/PACKAG
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG (MDR); boetzingerstr. 41; freiburg
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG (MDR); boetzingerstr. 41; freiburg
• Manufacturer Contact: jonathan schell ; boetzingerstr. 41; freiburg ; 76145120
• MDR Report Key: 5022462
• MDR Text Key: 24682907
• Report Number: 0008010177-2015-00212
• 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: Followup
• Report Date: 04/14/2015

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: Health Professional
• Device Catalogue Number: 50-19005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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