MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 75004650

Device Problems Break (1069); Insufficient Information (3190)

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

Event Date 08/27/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, a nail prox drop had a connecting issue and the other reported devices were cracked or broken.As this was noticed upon field inspection, there was not patient involvement.

Manufacturer Narrative

H3, h6: it was reported that a polarstem stem inserter was cracked or broken.As this was noticed upon field inspection, there was not patient involvement.The device, used in treatment, was not returned for evaluation.Thus, the relationship between the reported event and the device cannot be confirmed.The product history was reviewed.There was no further complaint reported for the batch in scope.A review of the production documentation did not reveal any deviations from standard manufacturing processes.There is no indication that the part failed to match specification at the time of manufacturing.Since the failure is not described in detail and no picture or part is available, the root cause cannot be determined.There is insufficient information available to determine any contributing factors.Should the part be returned, the complaint will be reopened.To date, no further actions are deemed necessary.The device will be monitored for further similar issues.

• Brand Name: POLARSTEM STEM INSERTER
• 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: 12489441
• MDR Text Key: 271985047
• Report Number: 9613369-2021-00366
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611996097573
• UDI-Public: 07611996097573
• 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: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75004650
• Device Catalogue Number: 75004650
• Device Lot Number: E68726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1