MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, DIAM.2.0X10MM, (5/PACKAGE); IMPLANT

Catalog Number 50-20410

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/09/2016

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 during surgery, a screw head broke from the screw shaft and the shaft remains implanted in the patient.However, the surgery was completed successfully.

Manufacturer Narrative

It was originally reported that the device would be returned, however, the broken off screw fragments have not been returned and the reported event cannot be confirmed.A review of the risk management file, revealed the following possible root causes: -incorrectly selected implants -insufficient/too high bone quality -wrong/ missing information -reuse of single use devices -wrong/ missing functionality check -improper implant placement (e.G.Arch bar, screw.) -too much/ wrong forces between blade, screw and bone (e.G.Screw head deformation, screw breakage) -power tool usage for screw insertion (not qdm) -too much/ wrong compression/ torsional/ axial forces -wrong rotational speed, unintended loads -bone quality resulting in high torque -improper blade disengaging -collision with other implant or instrument -predrilled hole not deep enough (e.G.Wrong choice of instrument/implant, system mix-up, poorly assembled/used instrument).Based on the statistical evaluation there is no indication for any systematic design, material or manufacturing related issue.The complaint is added to the complaint trend.

Event Description

It was reported that during surgery, a screw head broke from the screw shaft and the shaft remains implanted in the patient.However, the surgery was completed successfully.

• Brand Name: BONE SCREWS, CROSS-PIN, DIAM.2.0X10MM, (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: 5739998
• MDR Text Key: 48735117
• Report Number: 0008010177-2016-00138
• 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: 06/10/2016

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: 50-20410
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2016
• Initial Date FDA Received: 06/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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