MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN HOFFMANN3 RODS; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number UNK_SEL

Device Problem Unclear Information (4052)

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

Event Date 05/31/2022

Event Type  malfunction  

Event Description

As reported: "a customer has concerns regarding the reprocessing of hoffmann rods due to stryker symbols not correlating with hse symbol reprocessing guidelines"."the symbol with the 2 in a circle which is on the hoffmann3 rods, means single patient use and can remain on the set, but must be discarded once used on a patient as such it can be reprocessed.However the hse guidelines reference this symbol as not to be reprocessed".

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.

Manufacturer Narrative

The complaint could be confirmed, since the returned information for evaluation matches the alleged failure.Evaluation of the received information has shown, that the provided hse guidelines is not a document under the control of stryker, therefore we can only refer to our ifu.Furthermore, the mentioned point in the hse guidelines does not correspond to the requirements of the stryker ifu.The current surgical technique and ifu (instructions for use) state: "products which have already been used in a surgically invasive manner, even if implanted only partly or temporarily during the surgical procedure, must not be reprocessed for reuse.All vectran coated carbon connecting rods are intended for single patient use only.Once used on a patient they have to be disposed of.Unused rods can be reprocessed in the tray according to the cleaning and sterilization instructions mentioned in the package insert.Tests have shown intended performance for 50 reprocessing cycles.¿ a review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.Based on investigation, the root cause was attributed to a customer documentation issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

As reported: "a customer has concerns regarding the reprocessing of hoffmann rods due to stryker symbols not correlating with hse symbol reprocessing guidelines"."the symbol with the 2 in a circle which is on the hoffmann3 rods, means single patient use and can remain on the set, but must be discarded once used on a patient as such it can be reprocessed.However the hse guidelines reference this symbol as not to be reprocessed".

• Brand Name: UNKNOWN HOFFMANN3 RODS
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14826935
• MDR Text Key: 303293557
• Report Number: 0008031020-2022-00287
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1