MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM DAA OFFSET ADAPTER 45; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	75103197
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint reference: (b)(4).
Event or Problem Description
It was reported that the distance of the instrument between rasp adapter and spring should be 3 cm longer, since the spring releases unintentionally with each hammer blow and the rasp therefore comes off the adapter or is released too early and has to be put back on.The procedure was completed using the same device.A delay of 10 minutes or less was reported.The problem occurs whilst using the daa (direct anterior approach) surgical method (access to the hip joint).
Additional Manufacturer Narrative
H3, h6: it was reported that the distance of the instrument between rasp adapter and spring should be 3 cm longer, since the spring releases unintentionally with each hammer blow and the rasp therefore comes off the adapter or is released too early and has to be put back on.The procedure was completed using the same device.A delay of 10 minutes or less was reported.The device, used in treatment, was not returned for investigation.A product evaluation could therefore not be performed.Nevertheless, the batch number was reported and the production documentation review was performed.A review of the past complaints revealed no additional complaint device for batch a70364, nor for article 75103197 so far.Furthermore, a market feedback of countries was obtained, where the daa offset adapter 45 was delivered.No other similar issues with the device are known so far.The production documentation was reviewed as well.No deviation was detected from the standard manufacturing process which could have affected the device performance.According to the performed sawbone and cadaver surgeries with a prototype device v0, the outcome was that the instrument fits to the rasps and that this connection was assessed to be stable and secure.Based on the available information, the reported failure mode could not be confirmed as the complained part was not returned for product evaluation.Hence, the root cause of the reported incident could not be established.The unintentional spring release is contrary to the expectations of the cadaver/sawbone report.According to the document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.Furthermore, the relevant surgical technique, illustrates in detail, how offset adapter devices should be used.To conclude, there are no similar complaints known for this device until now and there is no indication that the device failed to match specification at the time of manufacturing.The device design was validated and functioned as intended.The need for corrective action is therefore not indicated.Nevertheless, smith and nephew will continue to monitor the device for similar issues.Should additional information become available, this complaint will be reassessed.This investigation is considered closed.

• Brand Name: POLARSTEM DAA OFFSET ADAPTER 45
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11468401
• Report Number: 9613369-2021-00111
• Device Sequence Number: 3834880
• Product Code: MDM
• UDI-Device Identifier: 00885556724385
• UDI-Public: 885556724385
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/09/2021

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 Catalogue Number: 75103197
• Device Lot Number: A70364
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 05/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1