MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SINGLE USE INSTRUMENTS - FEMORAL KIT (PS) - SIZE 7; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 5555-2257

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

Primary procedure, knee, side unknown.It was reported that in opening the disposable 4-in-1 cutting block, the 2 alignment pins were reported to have pierced through the wrapping.Due to sterility concerns, the device was not used.Another device was available with an approximate 2 minute surgical delay.The procedure was otherwise completed successfully.

Manufacturer Narrative

An event regarding a packaging issue involving a single use instruments - femoral kit (ps) - size 7 was reported.The event was confirmed.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other events for the lot referenced.Conclusion: the reported event is confirmed.Holes were noticed on the tyvek sheet of the inner and outer pouch however, the root cause could not be determined.Discussion with packaging indicated that the returned product was packaged per the drawing (b)(4), rev a and found that it met specification.The packaging and the contents appear intact.Also, there are visual inspection checks during packaging.As per millstone box-out procedure, (b)(4), rev 2 these devices would not have been released if there was any visual damage.The issue could have incurred during shipment/handling.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Primary procedure, knee, side unknown.It was reported that in opening the disposable 4-in-1 cutting block, the 2 alignment pins were reported to have pierced through the wrapping.Due to sterility concerns, the device was not used.Another device was available with an approximate 2 minute surgical delay.The procedure was otherwise completed successfully.

• Brand Name: SINGLE USE INSTRUMENTS - FEMORAL KIT (PS) - SIZE 7
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7417372
• MDR Text Key: 105376597
• Report Number: 0002249697-2018-01073
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K172326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 5555-2257
• Device Lot Number: 19021401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR