MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HEADED NAILS - 1 1/2"; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 6541-4-515

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event 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.".

Event 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.".

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 NAILS - 1 1/2"
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8797748
• MDR Text Key: 151319919
• Report Number: 0002249697-2019-02590
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327241402
• UDI-Public: 07613327241402
• Combination Product (y/n): N
• PMA/PMN Number: K143393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• Device Catalogue Number: 6541-4-515
• Device Lot Number: SS18716A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 09/18/2019
• Supplement Dates FDA Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other