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

Model Number 75100471

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2021

Event Type  Injury  

Event Description

It was reported that during the opening the envelope of a polarstem stem std ti/ha 8 non-cem was punctured and there was no vacuum.As this was noticed during set up, the procedure was performed, without any delay, using a s+n back-up device.Patient was not impacted.

Manufacturer Narrative

H6: it was reported that during the opening the envelope of a polarstem stem std ti/ha 8 non-cem was punctured and there was no vacuum.As this was noticed during set up, the procedure was performed, without any delay, using a s+n back-up device.Patient was not impacted.The device, which intent use is in treatment, was returned for investigation.The reported failure mode can clearly be identified.The stem is not fixed in the package any more, several scratches can be seen on the inside and a hole in the distal part is visible.The production records were reviewed but no deviations found.For the batch in scope no other complaint was reported.There is no indication that the device failed to match specification at the time of manufacturing and when released for distribution.According to our instructions for use implants may not be implanted under any circumstances if the packaging is damaged or not intact.The risk is covered within our product specific risk file.The root cause can not be established and no potential contributing factor can be identified.To date no corrective or preventive actions are planned.S+n will monitor this device for similar issues.

• Brand Name: POLARSTEM STEM STD TI/HA 8 NON-CEM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11808829
• MDR Text Key: 250413716
• Report Number: 9613369-2021-00201
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611996118629
• UDI-Public: 07611996118629
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75100471
• Device Catalogue Number: 75100471
• Device Lot Number: B1715102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Date Manufacturer Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1