MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UNIVERSAL BONE REPOSITIONING INSTRUMENT, DIAM.3.2MM

Model Number 62-32440

Device Problem Fracture (1260)

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

Event Date 10/02/2019

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

During surgical case, a repositioning pin fractured in half.No adverse consequences to patient or staff.No delay in surgery as backup products were available.

Event Description

During surgical case, a re positioning pin fractured in half.No adverse consequences to patient or staff.No delay in surgery as backup products were available.

Manufacturer Narrative

Update: the investigation shows that the product subject to the complaint had reached its life time at the event date of the reported incident.The relevant quality documents indicate that the product was manufactured according to specifications and was accepted into stock without any discrepancies.There is no indication for a quality issue with the article in question, nor is there any indication for a deviation from the defined quality specifications within development or manufacturing.No indications for unusual or unexpected circumstances could be identified, either.Moreover it is to be concluded that the reported incident originated from a common case of wear and tear resulting from aging as it is to be expected with mechanical medical devices subject to reprocessing after reaching their life time, not making any further action necessary.This complaint will be considered in statistical analyses at frequent intervals.The reported event could not be confirmed, as the device was not returned for evaluation (screw head was discarded by customer).In a follow-up request, the sales representative has stated that blade 62-12170 was used during procedure and no pre-drilling was performed.However, the used blade 62-12170 is part of the standard screwdriver blades from the universal 2 system.It is not intended to be used for 1.2/1.7 mm axs screws.This may have been the cause for the reported screw breakage.In the related instructions for use (ifu# 90-01943), it is stated that ¿1.2mm and 1.7mm axs screws utilize the same screwdriver blades.They are only compatible with the axs screwdriver blades 1.2/1.7mm.The axs screwdriver blades 1.2/1.7mm are marked with one orange band and one yellow band on the shaft.Within the axs screwdriver blades 1.2/1.7mm the orange band is located closer to the blade tip to distinguish it from the standard screwdriver blades where the yellow band is located closer to the blade tip¿.Possible root causes according to the related risk management are: mixup and /or wrongly assembled instruments/ implants.Insufficient/too high bone quality.Wrong/ missing information.Incorrectly selected/ assembled implant/ instrument.Too much/ wrong compression/ torsional/ axial forces.Bone quality resulting in high torque.Improper blade disengaging.Based on statistical evaluation there are no indications for any systematic design, material or manufacturing related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.

• Brand Name: UNIVERSAL BONE REPOSITIONING INSTRUMENT, DIAM.3.2MM
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• MDR Report Key: 9199210
• MDR Text Key: 168467581
• Report Number: 0008010177-2019-00063
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07613153171096
• UDI-Public: 07613153171096
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

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 Model Number: 62-32440
• Device Catalogue Number: 62-32440
• Device Lot Number: N/A STOCKED IN SET
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 10/03/2019
• Supplement Dates FDA Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1