MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GUIDE WIRE RULER T2 TIBIA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 1806-0022

Device Problem Residue After Decontamination (2325)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event Description

As reported: "during a case where a loan set of t2 humerus was being used, it was noticed during the case that there was an unknown substance stuck to the guide wire ruler (1806-0022) from the t2 basic short tray (item: 18069905-t lot# 4239721).This meant the item was unsterile and could not be used.An alternative means of measuring was adopted and it caused a slight delay to surgery.The surgeon stated at the end of the procedure that the secondary method of measuring we used ended up causing an inaccurate measurement, which meant the t2 humeral nail that was implanted was too short.The implant was not changed.Noticed during the procedure, just before the guide wire ruler was about to be used.".

Manufacturer Narrative

Correction: refer to h6 method code.The reported event could be confirmed, although the device was not returned for evaluation, but a few images of the device were shared for evaluation.A physical device inspection was not possible since the affected device was not returned, however; a images were shared of the device which shows the alleged contamination.The inside of the handle portion was found to have encrustation of blood/residues along with visible blood stains and other residues.The device had clearly not been thoroughly reprocessed.The batch record could not be reviewed because the affected device was not returned and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Similar issue of residue on a device was evaluated by a medical expert previously.His comments (excerpts): ¿a surgical instrument with residuals of body fluids or human tissue has no increased risk of infection, if a sufficient sterilization procedure has been made (¿sterile crud¿).¿ only in the (very rare) case of significant contamination with body fluids from a previous patient with massive infection of lps producing germs a small load of endotoxins (lps) may cause a limited local inflammation, which will be hardly registered by the patient.¿ otherwise, no negative side effects for the patient have to be expected, if a surgical instrument is contaminated with (incrusted) residuals of body fluids or human tissue from previous surgeries due to insufficient cleaning and / or the design of the instrument, which would not allow for perfect cleaning.¿ based on the information given and the images provided, it gives a clear indication towards an inadequate reprocessing procedure employed by the user.The device was not thoroughly cleaned before sterilizing it, hence the encrustation occurred, and other form of residue also remained.If any additional information is provided, the investigation will be reassessed.

Event Description

As reported: "during a case where a loan set of t2 humerus was being used, it was noticed during the case that there was an unknown substance stuck to the guide wire ruler (1806-0022) from the t2 basic short tray (item: 18069905-t lot# 4239721).This meant the item was unsterile and could not be used.An alternative means of measuring was adopted and it caused a slight delay to surgery.The surgeon stated at the end of the procedure that the secondary method of measuring we used ended up causing an inaccurate measurement, which meant the t2 humeral nail that was implanted was too short.The implant was not changed.Noticed during the procedure, just before the guide wire ruler was about to be used.".

• Brand Name: GUIDE WIRE RULER T2 TIBIA
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10997119
• MDR Text Key: 221278418
• Report Number: 0009610622-2020-00920
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04546540195784
• UDI-Public: 04546540195784
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1806-0022
• Device Catalogue Number: 18060022
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR