MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR REAMER GUIDE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75102205
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that, a polarstem collar reamer guide failed an inspection.The device, used in treatment, was returned for evaluation.It can be confirmed that the hook of the device is broken.The distal hook of the device was not returned for evaluation.A material evaluation shows that the hook broke due to a high impact.The relationship between the reported event and the device can be confirmed.The production documentation was reviewed, there were no deviations found.There are no indications that the part failed to match specification at the time of manufacturing. for the batch in scope, no further complaint was reported.This is the first complaint for this design version of this device and therefore an isolated event.Without the return of the missing fragment of the hook, it is not possible to speculate about factors which could have contributed to the reported event.To date, no probable root cause can be determined.No further actions are deemed necessary, however this device will be monitored for further similar complaints.
Event or Problem Description
It was reported that a polarstem collar reamer guide failed the inspection.As this was noticed in a field inspection, no patient was involved.The results of investigation confirmed that this product was fractured, which makes it a reportable event.
Additional Manufacturer Narrative
It was reported that, a polarstem collar reamer guide failed an inspection.The device, used in treatment, was returned for evaluation.It can be confirmed that the hook of the device is broken.The distal hook of the device was not returned for evaluation.A material evaluation shows that the hook broke due to a high impact.The relationship between the reported event and the device can be confirmed.The production documentation was reviewed, there were no deviations found.There are no indications that the part failed to match specification at the time of manufacturing.For the batch in scope, no further complaint was reported.This is the first complaint for this design version of this device and therefore an isolated event.Without the return of the missing fragment of the hook, it is not possible to speculate about factors which could have contributed to the reported event.To date, no probable root cause can be determined.No further actions are deemed necessary, however this device will be monitored for further similar complaints.

• Brand Name: POLARSTEM COLLAR REAMER GUIDE
• 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: 12370529
• Report Number: 9613369-2021-00349
• Device Sequence Number: 11074018
• Product Code: LXH
• UDI-Device Identifier: 00885556535493
• UDI-Public: 00885556535493
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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: 75102205
• Device Catalogue Number: 75102205
• Device Lot Number: B70357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1