MAUDE Adverse Event Report: ORTHALIGN, INC. IMPACTOR ADAPTER- S/B

Model Number	403028
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hip Fracture (2349); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported inability to disassemble the cup will be investigated once the product is returned.Orthalign is filing this mdr in an abundance of caution due to the outcome of this case and the potential connection to the hipalign system.
Event or Problem Description
It was reported that total hip arthroplasty was performed with hipalign.After cup impaction with 48mm cup, the surgeon tried to disengage from cup and impactor.However, he was unable to disassemble the cup.Subsequently, two surgeons disengaged the cup with force.The patient acetabular was little damaged by disassembly so bigger cup (50mm) was used to complete the procedure.
Additional Manufacturer Narrative
Only the impactor adaptor was returned.Upon visual inspection, the threads of the adaptor look to be completely intact.A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.Orthalign, inc.Will continue to monitor this issue and take action if alert limits are exceeded.

• Brand Name: IMPACTOR ADAPTER- S/B
• Common Device Name: IMPACTOR ADAPTER
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo, ca
• MDR Report Key: 10377134
• Report Number: 3007521480-2020-00010
• Device Sequence Number: 11236925
• Product Code: OLO
• UDI-Device Identifier: 00858704006565
• UDI-Public: 00858704006565
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 403028
• Device Catalogue Number: 403028
• Device Lot Number: 10808VZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention