MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HEADED NAIL - 3/4"; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	6541-4-575
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
There are 6541-4-575 3/4¿ headed nails in 6541-4-515 1 1/2¿ packaging.There were 2 delivered this way to (b)(6).Update: "they were delivered to the hospital new, unopened.A sterile processing employee opened one and realized it was the wrong pin (3/4¿ pin in a package labeled as 1 1/2¿ pin).They left the second package unopened.We are returning both.".
Event or Problem Description
There are 6541-4-575 3/4¿ headed nails in 6541-4-515 1 1/2¿ packaging.There were 2 delivered this way to community general.Update: "they were delivered to the hospital new, unopened.A sterile processing employee opened one and realized it was the wrong pin(3/4¿ pin in a package labeled as 1 1/2¿ pin).They left the second package unopened.We are returning both.".
Additional Manufacturer Narrative
Triathlon headed nails (6541-4-5xx) are sold as non-sterile instruments in packages with an outer label that contains information for the product (nail) description, part number, and lot code.Once the nails are removed from their packaging, the packaging is discarded, and the nails are placed into an instrumentation tray and queued for sterilization.The triathlon headed nails must be sterilized prior to surgical use.The device was discovered prior to surgery during kit preparation with no patient involvement and no adverse consequences reported.A sofha (severity of harm assessment) was conducted and concluded the highest potential of harm would be an s1 for a knee surgery with tourniquet.Based upon this review, it is unlikely that a serious injury or death would result if this event were to recur.Therefore, this event was re assessed as not reportable.

• Brand Name: HEADED NAIL - 3/4"
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8797750
• Report Number: 0002249697-2019-02589
• Device Sequence Number: 10819612
• Product Code: MBH
• UDI-Device Identifier: 07613327241457
• UDI-Public: 07613327241457
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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 Catalogue Number: 6541-4-575
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 09/19/2019
• 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