MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SUPRACONDYLAR NAIL T2 SCN 11X340MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1826-1134S
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
The physician found plastic powder on the device at opening of the packaging.According to the physician, the plastic powder seemed to be the wear powder of a sponge pad.The device was used for the procedure after washing it with saline.
Event or Problem Description
As reported: "the physician found plastic powder on the device at opening of the packaging.According to the physician, the plastic powder seemed to be the wear powder of a sponge pad.The device was used for the procedure after washing it with saline".
Additional Manufacturer Narrative
H6 results and conclusion codes were changed.The reported event could partially be confirmed, since pictures were provided by the customer, and show some foam particles on the package.A peer review by the quality team was performed and states that: "[.] the picture submitted by the customer shows abrasion in the foam inlay.In connection with this abrasion, the particles can be seen.These particles could be caused by the proximal nail end.Furthermore, two distinctive longer notches are visible.Due to the packaging design, the implant is buffered on both sides with foams inlays so that it cannot move in the longitudinal direction.The notches can therefore not be explained.[.] the work order was packed at the stryker kiel repackaging center in (b)(6) 2018.The sterile packaging was done according to specification.The correct amount of foam is specified in the appendix of the manufacturing specifications.The packaging materials were visually inspected for defects before use.The blisters were inspected regarding debris/particles after sealing.Both inspections passed.Therefore, there is no indication that the packaging was incorrect or that the damage occurred during manufacturing.The device in scope of the associated peer review is packed in its packaging system according to the packaging system design file.[.]all products in scope are packed with an appropriate amount of foam inlays to fill up the space between the product and the blister cavity and therefore to limit the degree of freedom.[.]the packaging performance test was passed with regards to seal integrity, whole packaging integrity, visual inspection of the labelling, seal width measurements and seal strength.[.]compared to the damage reported in the complaint, the abnormalities after packaging performance testing were much smaller.The damage shown in an image sent by the customer, can therefore not be reconstructed.Since the worst case [during testing] was correctly selected and there were no abnormalities regarding particles during the packaging performance test, the packaging performance of this packaging system is considered to be sufficient.[.] the particles complained about by the customer can therefore only be traced back to improper and inadequate handling during transport, handling, and storage from the current point of view and with the data provided by the customer.Due to the evaluation above, the risks regarding an insufficient packaging design regarding abrasion and packaging material particles are reduced as low as possible taking into account the current state of the art.[.]" as a conclusion, the investigation shows that the device was correctly packaged and inspected in the proper packaging.Packaging tests based on a worst scenario approach (using the heaviest nail possible), show that the foam inlays filling up the space between the product and the blister cavity limit the degree of freedom of the device, not allowing it to cause the reported debris.The particles reported by the customer can therefore only be traced back to improper and inadequate handling during transport, handling, or storage.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.If more information is provided, the case will be reassessed.

• Brand Name: SUPRACONDYLAR NAIL T2 SCN 11X340MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11812528
• Report Number: 0009610622-2021-00512
• Device Sequence Number: 19781371
• Product Code: HSB
• UDI-Device Identifier: 04546540378989
• UDI-Public: 04546540378989
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K023267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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: 07/31/2023
• Device Model Number: 1826-1134S
• Device Catalogue Number: 18261134S
• Device Lot Number: K0284F3RA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1