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

Model Number	75004650
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem 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.
Additional 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
• 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: 12489441
• Report Number: 9613369-2021-00366
• Device Sequence Number: 11610948
• Product Code: LXH
• UDI-Device Identifier: 07611996097573
• UDI-Public: 07611996097573
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2021

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 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
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1