MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 8 NON-CEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75100471
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a total hip procedure, the box was opened and the outer packaging was fine, but when the circulator went to hand the implant to the surgical tech, the implant was poking out of the plastic.The procedure was completed using a sn backup device.A delay of 30 min or less was reported.
Additional Manufacturer Narrative
It was reported that during a total hip procedure, the package was opened and the outer packaging was fine, but when the circulator went to hand the implant to the surgical tech, the implant was poking out of the plastic.The procedure was completed using a smith + nephew backup device.A delay of 30 min or less was reported.The claimed device is a polarstem standard ti/ha stem size 8 [article no.: 75100471, lot no.: a1409467], which intent use is in treatment.The device including claimed packaging was returned for investigation.The outer packaging as well as the first peel pouch were already open in the designated places.The second peel pouch has a tear parallel to the bottom seal seam.The innermost peel pouch has a hole through which the stem broke.The cone protection cap lies loose in the innermost bag and is no longer fixed to the stem.There are scratches and wiping visible in the innermost pouch.Everything indicates that the stem was not ideally fixed in the entire packaging construction and has moved, whereupon the damage can be traced back.A production history review was performed.The batch was manufactured and packed back in 2014.In the corresponding production record no deviations were found which could explain the missing vacuum or movement of the stem.For the reported batch number no other complaint can be found.For this specific article 6 additional complaints were recorded which claims a faulty device packaging and a loss of vacuum or damaged peel-pouches.The risk of a tear, rip or hole in the device packaging is covered within our corresponding packaging risk file and rated as low.After the performed investigation the root cause for this failure can not be confirmed.Further activities will not be planned.Repeated stock manipulations may have contributed to the motion of the stem inside the packaging causing the observed sterility breach.According to our instructions for use, implants may not be implanted under any circumstances if the packaging is damaged or not intact.If this scenario occurs, we kindly ask you to return the affected products (the peel pouches and the corresponding stems) to the appropriate smith & nephew representative or office for investigation.This complaint will be closed.Smith+nephew will however continue to monitor the corresponding products for similar issues.

• Brand Name: POLARSTEM STEM STD TI/HA 8 NON-CEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11646730
• Report Number: 9613369-2021-00150
• Device Sequence Number: 3097825
• Product Code: LXH
• UDI-Device Identifier: 07611996118629
• UDI-Public: 07611996118629
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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: 07/28/2021
• Device Model Number: 75100471
• Device Catalogue Number: 75100471
• Device Lot Number: A1409467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/11/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1