MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG SCREWDRIVER BLADE, FOR 1.5/1.7MM EMERGENCY SCREWS, CROSS-PIN; INSTRUMENT

Catalog Number 62-15000

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Loose or Intermittent Connection (1371); Fitting Problem (2183)

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

Event Date 03/19/2014

Event Type  malfunction  

Event Description

It was reported that screwdriver blades did not pick up the screws.They were very inconsistent, some don't pick up the screws, some do not hold the screws, and screw falls off.

Manufacturer Narrative

Investigation in progress but not yet complete.

Manufacturer Narrative

Because no devices were returned for investigation a confirmation of the reported event was not applicable.Nevertheless based on the reported event it was stated that the screwdriver blade 62-15000 (component of the universal neuro system) do not hold the screws with (b)(4).The mentioned screws are implants related to the universal neuro ii system.According to the relevant instruction for use (b)(4) it is stated that ¿all products out of the new stryker leibinger universal neuro ii system are not compatible to the existing stryker leibinger universal neuro system¿.Furthermore the information of the reported event was forwarded to the responsible r&d department which was providing and verifying the information that the screwdriver blade with (b)(4) correlates to the universal neuro system and the mentioned screw with (b)(4) correlates to the universal neuro ii system which were not compatible to each other.For the screw the related screwdriver blade is marked with (b)(4) and three teal color rings.Consequently the reported event indicates an off-label use while using components of not compatible systems.Therefore the root cause for the reported event can be attributed to a user related issue.Indications for any manufacturing, systematic or design related problems were not determined in the statistical evaluation.Product surveillance will continue to monitor complaints of this type for adverse trends and the complaint is added to the complaint trend.Device was unable to be returned.

Event Description

It was reported that screwdriver blades did not pick up the screws.They were very inconsistent, some don't pick up the screws, some do not hold the screws, and screw falls off.

• Brand Name: SCREWDRIVER BLADE, FOR 1.5/1.7MM EMERGENCY SCREWS, CROSS-PIN
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-79 111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-79 111
• Manufacturer Contact: kelli dykstra ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 3745961
• MDR Text Key: 16914987
• Report Number: 0008010177-2014-00088
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 03/19/2014

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: 62-15000
• Device Lot Number: 1000120297
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2014
• Initial Date FDA Received: 04/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1