MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG DAA DOUBLE OFFSET ADAPTER RIGHT 80/45; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	75102240
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the double offset adapter will not stay locked in place and needs to be replaced.Failure was detected during set up or inspection.Therefore, no patient involvement.
Additional Manufacturer Narrative
H3, h6: it was reported that the double offset adapter right will not stay locked in place and needs to be replaced.The failure was detected during set up or inspection and therefore, no patient was involved.The device, intended for use in treatment, was returned for investigation.Upon visual inspection, the reported failure mode could not be confirmed.The device shows limited signs of use such as small dents and scratches, but no damage is observed on the connector site to the broach.Furthermore, the instrument was tested with gauge id-nr 0723.No deviation was detected.One additional complaint but with another reported failure mode was reported for the batch in question (a59149).A review of the production documentation for the batch in scope did not reveal any deviation from the standard operating procedure.To conclude, based on the performed investigations, the reported failure mode could not be confirmed.However, previous investigations demonstrated that under specific circumstances the double offset adapter 80/45 may disconnect from the rasp during backslapping.An optimized design of the device has been released in order to reduce the occurrence of this issue.This version of the device will be monitored for similar issues.The returned device will be discarded.This investigation is considered closed.

• Brand Name: DAA DOUBLE OFFSET ADAPTER RIGHT 80/45
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11617772
• Report Number: 9613369-2021-00145
• Device Sequence Number: 11679538
• Product Code: JDI
• UDI-Device Identifier: 00885556535394
• UDI-Public: 00885556535394
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: 75102240
• Device Catalogue Number: 75102240
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1