MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, PARTIALLY THREADED T2 TIBIA Ø5X30 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18915030S
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
When nurse opened the sterile screw box, she saw a little hair (looks like an eye lash or eyebrow).Surgery was delayed a little - according to details received, less than 15 min.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was unpacked.The device inspection revealed the following: we received the locking screw, without overwrap-foil, in its original packaging.After unpacking the blister becomes visible with a completely pulled off tyvek® lid.Inspection of the tyvek® lid revealed a hair [like an eye-lash] at the bottom site at the area of the rim, which could be easily captured.The locking screw shows no traces of use.The reported event could not be reproduced as the packaging was received with an already broken sealing.Pollution in original condition could not be verified.Due to adhesive power of the glued / sealed connection of tyvek - blister a white colored area remains on the blister when the tyvek® lid is torn off.This white area is called crazing or stress-whitening.A consistent white and not interrupted surface indicates that no sealed-in foreign material (e.G.Hair) at the sealed area of the blister rim was present.In case of a sealed in hair a negative imprint would be apparent at the stress-whitening.Furthermore, not enough information is available to confirm the reported case.No deviations were reported during in-control steps performed.Finally, it could not be excluded that the pollution occurred at the user site.Based on the above observations the root cause could not be determined.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.
Event or Problem Description
When nurse opened the sterile screw box, en she saw a little hair( looks like a eye lash or eyebrow).Surgery was delayed a little - according to details received less than 15 min.

• Brand Name: LOCKING SCREW, PARTIALLY THREADED T2 TIBIA Ø5X30 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; postfach; schoenkirchen/kiel D-242 32
• MDR Report Key: 8487570
• Report Number: 0008031020-2019-00348
• Device Sequence Number: 1955642
• Product Code: HSB
• UDI-Device Identifier: 04546540201911
• UDI-Public: 04546540201911
• Combination Product (Y/N): N
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 18915030S
• Device Lot Number: K032E61
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other