MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 25MM; SCREW, FIXATION, BONE

Catalog Number 2030-6525-1

Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

It was reported that when circulating nurse opened the device, there was no screw in the packaging.The were also no stickers, inside was the full packaging - blister pack(s) and booklet but no device or stickers.Another screw was on hand and there was no surgical delay or adverse consequence to patient or user.

Manufacturer Narrative

Upon receipt of the package, further clarification from the sales representative was necessary.The package only contained the product box and ifu, and not the blister pack as initially described.The product was boxed and shrink wrapped on (b)(6) 2015.The only process where this failure could potentially occur is the contents to box operation.Beforehand, the sealing operation, is where an individual screw is loaded into one inner and one outer blister, and then sealed (sealing).From there, the sealed blisters are transported to the room where the blisters are packed into boxes and wrapped (contents-to-box).The operator performing this operation is responsible for loading the blister into the box and labeling the box.Afterwards, the box is wrapped by a separate operator who does not check for the box's contents.A full, visual inspection of the part and blister is required for the operator at the blister sealing operation, and the operator at the contents to box operation.A total of (b)(4) of each component was associated to this job and assembled for each part.This includes assembly items at both operations.In addition, the shrink wrap equipment station requires that all pieces included in each lot much be scanned into oracle before processing.Therefore, it can be concluded that (b)(4) parts were associated to this job at both the sealing and contents-to-box operation and not an overabundance of product.Another screw was on hand and there was no surgical delay or adverse consequence to patient or user.

Event Description

It was reported that when circulating nurse opened the device, there was no screw in the packaging.The were also no stickers, inside was the full packaging - blister pack(s) and booklet but no device or stickers.Another screw was on hand and there was no surgical delay or adverse consequence to patient or user.Sales rep clarified event by indicating the only thing inside of the box was the ifu.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 25MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5508899
• MDR Text Key: 40812568
• Report Number: 0002249697-2016-00912
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K894124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 2030-6525-1
• Device Lot Number: 92744D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 122